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Completed

NCT Number: NCT05339334

A Study to Learn About the Study Medicine PF-07321332 and Ritonavir in Adult Healthy Chinese Participants.

The purpose of this Phase 1 clinical trial is to help us understand how the drug is changed and eliminated from your body after you take it, the safety, and the the extent to which dise effects can be tolerated of PF-07321332 when PF-07321332 and ritonavir are given to healthy adult Chinese participants.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital,Fudan University

Shanghai, Shanghai Municipality, 201107, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Chinese participants
  • No clinical relevant abnormalities
  • Body mass index (BMI):17.5-28

Exclusion criteria

  • Any clinical significant illness
  • History of alcohol abuse
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior the first study dose
  • Abnormal clinical lab tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, estimated glomerular filtration rate (eGFR)
  • Abnormal vital signs, such 12-electrocardiogram (ECG), blood pressure and pulse rate
  • Blood donation within 60 days
  • History of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb)
  • Other medical or psychiatric may inappropriate for the study

Treatment and study plan

PF-07321332/ritonavir

Drug

PF-07321332/ritonavir will be given by mouth two times a day for 10 days

Primary outcomes

  1. PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    Cmax is maximum plasma concentration .

  2. PF-07321332 Maximum Observed Plasma Concentration (Cmax) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

    Cmax is maximum plasma concentration

  3. PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    Tmax is the time for maximum plasma concentration

  4. PF-07321332 Time for Maximum Observed Plasma Concentration (Tmax) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

    Tmax is the time for maximum plasma concentration

  5. PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    Area under the plasma concentration-time profile from time Zero to time point on 12 hours

  6. PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours) (AUCtau) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

    Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.

  7. PF-07321332 Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    This was determined by AUCtau/tau.

  8. PF-07321332 Accumulation Ratio for AUCtau (Rac) on Day 10

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    Accumulation ratio for AUCtau following multiple dosing was calculated as AUCtau on Day 10 divided by AUC12 on Day 1.

  9. PF-07321332 Accumulation Ratio for Cmax (Rac, Cmax) on Day 10

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours); Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

    Observed accumulation ratio for Cmax was calculated as Cmax on Day 10 divided by Cmax on Day 1.

  10. PF-07321332 Peak-to-trough Ratio (PTR) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    This was determined by Day 10 Cmax/Day 10 Ctrough.

  11. PF-07321332 Apparent Clearance (CL/F) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    Apparent oral clearance. This was determined by Dose/AUCtau.

  12. PF-07321332 Apparent Volume of Distribution (Vz/F) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    Apparent oral volume of distribution.

  13. PF-07321332 Terminal Elimination Half-life (t½) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)

    Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  14. PF-07321332 Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24 and 48 hours)

    Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)

  15. PF-07321332 Trough Concentration (Ctrough) on Day 5

    Time frame: Day 5 (pre-dose)

    Concentration at pre-dose on Day 5. Observed directly from data.

  16. PF-07321332 Trough Concentration (Ctrough) on Day 8

    Time frame: Day 8 (pre-dose)

    Concentration at pre-dose on Day 8. Observed directly from data.

  17. PF-07321332 Trough Concentration (Ctrough) on Day 10 (Pre-dose)

    Time frame: Day 10 (pre-dose)

    Concentration at pre-dose on Day 10. Observed directly from data.

  18. PF-07321332 Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)

    Time frame: Day 10 (12 hours after last dose)

    Concentration at 12 hour time on Day 10. Observed directly from data.

Secondary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From baseline up to Day 42

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent,pathogenic or non-pathogenic. An adverse event is considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study would be flagged as TEAEs.

  2. Number of Participants With Vital Signs Data Meeting Pre-Specified Categorization Criteria

    Time frame: Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)

    Vital signs evaluations included supine blood pressure (BP) and pulse rate. The pre specified criteria for vital signs included systolic blood pressure (BP) minimum (min.) less than (<) 90 millimeter of mercury (mmHg); systolic BP change from baseline maximum (max.) decrease >= 30 mmHg, max. increase >=30 mmHg; diastolic BP min. <50mmHg; diastolic BP change from baseline max. decrease >=20, max. increase >=20; seated pulse rate min. <40 beats per minute (bpm) and max. >120 bpm. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.

  3. Number of Participants With Laboratory Abnormalities

    Time frame: Day-1, Day 2, Day 5, Day 8, Day 10, Day 12.

    Safety laboratory assessments included hematology, urinalysis, and clinical chemistry.

  4. Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Categorization Criteria

    Time frame: Day 1 (pre-dose, within 1-2 hours after morning dose), Day 10 (pre-dose, within 1-2 hours after morning dose)

    The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average of the triplicate pre-dose recordings on Day 1. Pre-defined categories for corrected QT (Fridericia method) (QTcF): Absolute value (milliseconds[msec]) >450 and ≤480, or >480 and ≤500, or >500; Increase from baseline in QTcF (msec) >30 and ≤60, or>60. Pre-defined categories for PR and QRS: PR (msec) max. ≥300; PR (msec) increase from baseline: baseline >200 and max. ≥25% increase, or baseline ≤200 and max. ≥50% increase; QRS (msec) max. ≥140; QRS (msec) increase from baseline ≥50% increase. Participants who met at least 1 pre- specified criteria would be reported in outcome measure.

  5. Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    Cmax is maximum plasma concentration

  6. Ritonavir Maximum Observed Plasma Concentration (Cmax) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

    Cmax is maximum plasma concentration

  7. Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

    Tmax is the time for maximum plasma concentration

  8. Ritonavir Time for Maximum Observed Plasma Concentration (Tmax) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8 and 12 hours)

    Tmax is the time for maximum plasma concentration

  9. Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Point on 12 Hours (AUC12) on Day 1

    Time frame: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    This was determined by linear/Log trapezoidal method - reported as AUC12 on Day 1.

  10. Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to Time Tau (Where Tau=12 Hours [Twice Daily Dosing]) (AUCtau) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    Area under the plasma concentration-time profile from time 0 to the time of the end of the dosing interval (tau), where tau=12 hours.

  11. Ritonavir Area Under the Plasma Concentration-time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)

    Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (Clast)

  12. Ritonavir Average Plasma Concentration Over the Dosing Interval (Cav) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    This was determined by AUCtau/tau.

  13. Ritonavir Apparent Clearance (CL/F) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    Apparent oral clearance. This was determined by Dose/AUCtau.

  14. Ritonavir Apparent Volume of Distribution (Vz/F) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, and 12 hours)

    Apparent oral volume of distribution. This was determined by Dose/(AUCtau*kel)

  15. Ritonavir Terminal Elimination Half-life (t½) on Day 10

    Time frame: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, and 48 hours)

    Terminal half-life. This was determined by Loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.

  16. Ritonavir Trough Concentration (Ctrough) on Day 5

    Time frame: Day 5 (pre-dose)

    Concentration at pre-dose on Day 5. Observed directly from data.

  17. Ritonavir Trough Concentration (Ctrough) on Day 8

    Time frame: Day 8 (pre-dose)

    Concentration at pre-dose on Day 8. Observed directly from data.

  18. Ritonavir Trough Concentration (Ctrough) on Day 10 (Pre-dose)

    Time frame: Day 10 (pre-dose)

    Concentration at pre-dose on Day 10. Observed directly from data.

  19. Ritonavir Trough Concentration (Ctrough) on Day 10 (12 Hours After Last Dose)

    Time frame: Day 10 (12 hours after last dose)

    Concentration at 12 hour on Day 10. Observed directly from data.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Single Center, Open-label Study of PF-07321332 Administrated as Multiple Oral Doses in Healthy Chinese Participants.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2022
Registry last updated
Oct 8, 2024

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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