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Completed

NCT Number: NCT05441215

A Study to Learn About the Medicine (PF-07321332 or Nirmatrelvir/Ritonavir) in Healthy Lactating Women

The main purpose of this study is to measure the level of active ingredient of the study medicine (nirmatrelvir) that is secreted in human breast milk when it is given to healthy breastfeeding women. The study medicine consists of two medicines, nirmatrelvir and ritonavir. We are seeking female participants who are:

* Actively breast-feeding (lactating) at least 12 weeks postpartum; * Age between 18 to 55 years and not currently pregnant; * Have a Body Mass Index (BMI): 17.5 kg/m2; and a total body weight >50 kg (110 lb).

Participants will take the study medicine by mouth for a total of 3 times over 2 days (2 morning doses and 1 evening dose) at the study clinic. We will periodically collect breast milk from day 2 to 4 to measure the level of nirmatrelvir and ritonavir in it. A safety follow up call will be conducted around 28-35 days from the last dose to monitor any reactions participants may have to the study medicine.

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Key information

Conditions

Healthy Participants Behavior Breast Feeding COVID-19 Coronaviridae Infections Coronavirus Infections Feeding Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy lactating females who are actively breast-feeding or expressing breast milk, at least 12 weeks post-partum and not currently pregnant between 18 and 55 years old
  • Body Mass Index (BMI): 17.5 kg/m2; and a total body weight >50 kg (110 lb)
  • Infants of women enrolled in the study must be able to feed successfully from a bottle or other age-appropriate alternative feeding method prior to the start of the study and must be able to tolerate infant formula if the mother does not have a supply of stored breast milk sufficient to cover the duration of the study
  • Participants must be willing to temporarily discontinue breast feeding their infants for a total of 4.5 days (108 hours)
  • Participants must be willing to regularly pump breasts throughout the study and express milk according to a schedule designed to maintain lactation throughout the study period

Exclusion criteria

  • Positive test result (RT-PCR) for SARS-CoV-2 infection at the time of screening or Day -1
  • Evidence or history of clinically significant findings
  • History of febrile illness or mastitis within 5 days prior to the first dose of study medication
  • Participants who have received a COVID-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a COVID-19 vaccine at any time during the study confinement period
  • History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed
  • Abnormal vital signs such as blood pressure, 12-lead electrocardiogram
  • History of alcohol abuse and/or illicit drug use, tobacco use in excess of 5 cigarettes/day or 2 chews/day
  • Blood donation within 60 days

Treatment and study plan

nirmatrelvir

Drug

nirmatrelvir/ritonavir

Other names: PF-07321332/ritonavir

Ritonavir

Drug

nirmatrelvir/ritonavir

Other names: PF-07321332/ritonavir

Primary outcomes

  1. The Maximum Observed Concentration of Nirmatrelvir in Breast Milk Over the Dosing Interval

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The maximum observed concentration and was directly observed from data.

  2. Time to Reach Cmax of Nirmatrelvir in Breast Milk

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    Cmax was defined as maximum observed concentration of nirmatrelvir in breast milk.

  3. Area Under the Concentration-Time Profile From Time Zero to End of Dosing Interval for Nirmatrelvir in Breast Milk

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    Area under the concentration curve for nirmatrelvir in breast milk from time 0 to end of dosing interval.

  4. Terminal Half-Life of Nirmatrelvir in Breast Milk

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The time measured for the breast milk nirmatrelvir concentration to decrease by one half.

  5. The Average Steady State Concentration of Nirmatrelvir in Breast Milk

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.

  6. The Amount of Nirmatrelvir Excreted in Breast Milk Over the Dosing Interval Tau

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The amount of nirmatrelvir excreted into breast milk over the dosing interval.

  7. The Percent of Amount of Nirmatrelvir Excreted in Breast Milk Over The Dosing Interval Tau

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The percent of nirmatelvir excreted in breast milk to amount of breast milk over the dosing interval .

  8. Breast Milk Clearance of Nirmatrelvir

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    Clearance was defined as the apparent volume (Liter) of breast milk completely cleared the nirmatrelvir per hour.

Secondary outcomes

  1. The Maximum Observed Concentration of Ritonavir in Breast Milk Observed Over the Dosing Interval

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The maximum observed concentration and was directly observed from data.

  2. Time to Reach Cmax of Ritonavir in Breast Milk

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    Cmax was defined as maximum observed concentration of ritonavir in breast milk.

  3. Area Under the Concentration-Time Profile for Ritonavir in Breast Milk From Time Zero to End of Dosing Interval

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    Area under the concentration curve for ritonavir in breast milk from time 0 to end of dosing interval.

  4. Half-Life of Ritonavir in Breast Milk

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The time measured for the breast milk ritonavir concentration to decrease by one half.

  5. The Average Steady State Concentration of Ritonavir in Breast Milk

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.

  6. The Amount of Ritonavir Excreted in Breast Milk Over the Dosing Interval Tau

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The amount of ritonavir excreted into breast milk over the dosing interval.

  7. The Percent of Ritonavir Excreted in Breast Milk Over The Dosing Interval Tau

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The percent of ritonavir excreted in breast milk to amount of breast milk over the dosing interval.

  8. Breast Milk Clearance of Ritonavir

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    Clearance was defined as the apparent volume (L) of breast milk completely cleared the ritonavir per hour.

  9. The Maximum Observed Concentration of Nirmatrelvir in Plasma Observed Over the Dosing Interval

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    The maximum observed concentration and was directly observed from data.

  10. The Maximum Observed Concentration of Ritonavir in Plasma Observed Over the Dosing Interval

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    The maximum observed concentration and was directly observed from data.

  11. Area Under the Concentration-Time Profile for Nirmatrelvir in Plasma From Time Zero to End of Dosing Interval

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    Area under the concentration curve for nirmatrelvir in breast milk from time 0 to end of dosing interval.

  12. Area Under the Concentration-Time Profile for Ritonavir in Plasma From Time Zero to End of Dosing Interval

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    Area under the concentration curve for ritonavir in plasma from time 0 to end of dosing interval.

  13. Half-Life of Nirmatrelvir in Plasma

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    The time measured for the plasma nirmatrelvir concentration to decrease by one half.

  14. Half-Life of Ritonavir in Plasma

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    The time measured for the plasma ritonavir concentration to decrease by one half.

  15. The Minimum Plasma Concentration of Nirmatrelvir Observed Over the Dosing Interval

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    The minimum observed concentration and was directly observed from data.

  16. The Minimum Plasma Concentration of Ritonavir Observed Over the Dosing Interval

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    The minimum observed concentration and was directly observed from data.

  17. Time to Reach Cmax of Nirmatrelvir in Plasma

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    Cmax was defined as maximum observed concentration of nirmatrelvir in plasma.

  18. Time to Reach Cmax of Ritonavir in Plasma

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    Cmax was defined as maximum observed concentration of ritonavir in plasma.

  19. Apparent Clearance of Nirmatrelvir From Plasma

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    Clearance was defined as the apparent volume (L) of plasma completely cleared the nirmatrelvir per hour.

  20. Apparent Clearance of Ritonavir From Plasma

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    Clearance was defined as the apparent volume (L) of plasma completely cleared the ritonavir per hour.

  21. Apparent Volume of Nirmatrelvir Distribution

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose was influenced by the fraction absorbed.

  22. Apparent Volume of Ritonavir Distribution

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose was influenced by the fraction absorbed.

  23. The Average Steady State Concentration of Nirmatrelvir in Plasma

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.

  24. The Average Steady State Concentration of Ritonavir in Plasma

    Time frame: At 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 18, 24, 32, 40, 48 Hours Post Dose on Day 2

    The average concentration across time and can be calculated by dividing AUCtau by time. AUCtau was defined area under the concentration curve from time 0 to end of dosing interval.

  25. Daily (24 Hour) Amount of Nirmatrelvir Excreted in Breast Milk

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    Amount of nirmatrelvir excreted in breast milk in 24 hours.

  26. Daily (24 Hour) Amount of Ritonavir Excreted in Breast Milk

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    Amount of ritonavir excreted in breast milk in 24 hours.

  27. Milk to Plasma Ratio of Nirmatrelvir for AUCtau During Dosing Interval

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The ratio of area under the concentration-time profile for nirmatrelvir in milk to those in plasma from time zero to end of dosing interval.

  28. Milk to Plasma Ratio of Ritonavir for AUCtau During Dosing Interval

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The ratio of area under the concentration-time profile for ritonavir in milk to those in plasma from time zero to end of dosing interval.

  29. Milk to Plasma Ratio of Nirmatrelvir for Cmax During Dosing Interval

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The ratio of the maximum concentration of nirmatrelvir in breast milk to those in plasma observed over the dosing interval.

  30. Milk to Plasma Ratio of Ritonavir for Cmax During Dosing Interval

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    The ratio of the maximum concentration of ritonavir in breast milk to those in plasma observed over the dosing interval.

  31. Body Weight Normalized Infant Dose (BWNID) of Nirmatrelvir in mg/kg/Day

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    BWNID = MPAUCtau * Cav * 150 mL/kg/day, where 150 mL/kg/day^2 is the standardized milk consumption for an infant. MPAUCtau: Milk to plasma ratio for AUCtau. Cav: Average concentration.

  32. BWNID of Ritonavir in mg/kg/Day

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    BWNID = MPAUCtau * Cav * 150 mL/kg/day, where 150 mL/kg/day^2 is the standardized milk consumption for an infant. MPAUCtau: Milk to plasma ratio for AUCtau. Cav: Average concentration.

  33. Body Weight Normalized Maternal Dose (BWNMD) of Nirmatrelvir in mg/kg/Day

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    Maternal dose in mg/day (300 mg BID = 600 mg/day for nirmatrelvir and 100 mg BID = 200 mg/day for ritonavir) / maternal weight in kg at screening.

  34. BWNMD of Ritonavir in mg/kg/Day

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    Maternal dose in mg/day (300 mg BID = 600 mg/day for nirmatrelvir and 100 mg BID = 200 mg/day for ritonavir) / maternal weight in kg at screening.

  35. Infant Dose Expressed As % of Body Weight Normalized Maternal Dose (BWNIDPCM) for Nirmatrelvir

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    BWNIDPCM = 100 * BWNID / BWNMD.

  36. BWNIDPCM for Ritonavir

    Time frame: At Day -1 (24 Hours Prior to Dosing on Day 1), Pre-dose on Day 1, 0 to 2, 2 to 4, 4 to 8, 8 to 12, 12 to 24, 24 to 32, 32 to 40 and 40 to 48 Hours Post-dose on Day 2

    BWNIDPCM = 100 * BWNID / BWNMD.

  37. Number of Participants With Treatment Emergent Adverse Events

    Time frame: From the first dose of study treatment on Day 1 to up to 28 days after the last dose of study intervention on Day 2 (maximum to 30 days)

    An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs might arise from symptoms or other complaints reported to the investigator by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative), or they might arise from clinical findings of the investigator or other healthcare providers (clinical signs, test results, etc.). TEAEs were those with initial onset or increasing in severity after the first dose of study treatment.

  38. Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)

    Time frame: At Screening (Day -28 to Day -2), Day -1, and Day 4

    The laboratory abnormality parameters included urinalysis: urine bilirubin (>=1), urine hemoglobin (>=1) and leukocyte esterase (>=1).

  39. Number of Participants With Vital Signs Abnormalities

    Time frame: At Screening (Day -28 to Day -2), Pre-dose and 12 Hours post-dose on Day 1, Pre-dose and 48 Hours Post-dose on Day 2

    Single supine blood pressure (BP), and pulse rate (PR) were performed following approximately a 5-minute rest in a supine position. BP, and PR assessments will be performed after collection of electrocardiogram (ECGs) and prior to collection of blood draws if scheduled at the same time. Vital signs abnormality included supine systolic BP <90mmHg.

  40. Number of Participants With ECG Abnormalities

    Time frame: At Screening (from Day -28 to Day -2)

    Standard 12-lead ECGs utilizing limb leads (with a 10 second rhythm strip) were collected. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements.

  41. Number of Participants With Physical Examination Abnormalities

    Time frame: At Screening (from Day -28 to Day -2) or Day -1

    Physical examination included height, weight and body mass index (BMI, BMI = weight [kg] / height [m^2]) obtained for eligibility criteria. Physical examination abnormalities: BMI <17.5 kg/m^2; and a total body weight <=50 kg (110 lb).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE I, MULTIPLE DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF NIRMATRELVIR/RITONAVIR IN HEALTHY LACTATING WOMEN

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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