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Completed

NCT Number: NCT05064800

PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants

This is a drug-drug interaction study to assess the effects of PF-07321332/ritonavir and ritonavir on the Pharmacokinetic (PK) of dabigatran in healthy volunteers. PK will be evaluated for PF-07321332 and ritonavir. Dabigatran is being utilized as a P-gp substrate

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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

Research Centers of America ( Hollywood )

Hollywood, Florida, 33024, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index (BMI) of 17.5 to 30.5 kg.m2; and a total body weight >50 kg (110 lbs)
  • Female participants must have a negative pregnancy test

Exclusion criteria

  • Positive test for SARS-Co-V2 at the time of screening or Day -1
  • Active pathological bleeding or risk of bleeding
  • Positive urine drug test
  • History of sensitivity to heparin or heparin induced thrombocytopenia
  • Participants who have been vaccinated for COVID-19 in the past 7 days

Treatment and study plan

dabigatran

Drug

A single dose of Dabigatran on Day 1

PF-07321332/ritonavir + Dabigatran

Drug

PF-07321332/ritonavir twice daily (BID) for Days 1 and 2 Single dose of Dabigatran on Day 2

Ritonavir + Dabigatran

Drug

Ritonavir BID on Days 1 and 2 Single dose of Dabigatran on Day 2

Primary outcomes

  1. Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Maximum Plasma Concentration (Cmax)

    Time frame: Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

    Cmax was defined as maximum observed plasma concentration.

  2. Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUCinf

    Time frame: Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

    AUCinf was defined as the area under the plasma concentration-time curve from time 0 extrapolated to infinity

  3. Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUClast

    Time frame: Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

    AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration.

Secondary outcomes

  1. Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Maximum Plasma Concentration (Cmax)

    Time frame: Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

    Cmax was defined as maximum observed plasma concentration

  2. Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUCinf

    Time frame: Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

    AUCinf was defined as area under the plasma concentration-time curve from time 0 extrapolated to infinity

  3. Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUClast

    Time frame: Treatment 1 Day 1 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose. Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

    AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration.

  4. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study

    Time frame: From Pre-dose on Day 1 to Day 48

    An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.

  5. Number of Participants With Laboratory Test Abnormality (Without Regard to Baseline Abnormality)

    Time frame: From pre-dose on Day 1 to Day 3

    To determine if there are any clinically significant laboratory abnormalities, the haematological, clinical chemistry (serum) and urinalysis safety tests were assessed against the criteria specified in the sponsor reporting standards. Tests including Ery. Mean Corpuscular Hemoglobin, Eosinophils, Activated Partial Thromboplastin Time, Bilirubin, Fibrinogen, URINE Hemoglobin, Nitrite, and Leukocyte Esterase tests.

  6. Number of Participants With Vital Signs of Potential Clinical Concern

    Time frame: From pre-dose on Day 1 to Day 3

    Single supine blood pressure and pulse rate tests were assessed against the criteria specified in the sponsor reporting standards.

  7. Number of Participants With ECG Values of Potential Clinical Concern

    Time frame: From pre-dose on Day 1 to Day 3

    QT interval, QTc, PR, RR, QRS and heart rate tests were assessed against the criteria specified in the sponsor reporting standards.

  8. Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Time to First Occurrence of Cmax (Tmax)

    Time frame: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

    Tmax was defined as time to first occurrence of Cmax

  9. Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Tmax

    Time frame: Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

    Tmax was defined as time to first occurrence of Cmax.

  10. Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Terminal Half-life (t½)

    Time frame: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

    t½ was defined as terminal half-life of Dabigatran (Total) PK Parameters (PF-07321332/ritonavir co-administered with dabigatran.

  11. Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): t½

    Time frame: Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose

    t½ was defined as terminal half-life of Dabigatran (Total).

  12. Plasma PF-07321332 PK Parameters: Cmax

    Time frame: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose

  13. Plasma PF-07321332 PK Parameters: AUCtau

    Time frame: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose

    AUCtau was defined as area under the plasma concentration-time profile from time zero to time tau (τ) the dosing interval, where tau=12 hours for twice daily (BID) dosing.

  14. Plasma PF-07321332 PK Parameters: t½

    Time frame: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose

    t½ was defined as terminal half-life of PF-07321332.

  15. Plasma PF-07321332 PK Parameters: Tmax

    Time frame: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose

    Tmax was defined as time to first occurrence of Cmax.

  16. Plasma PF-07321332 PK Parameters: CL/F

    Time frame: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose

    CL/F was defined as apparent clearance of drug from plasma.

  17. Plasma PF-07321332 PK Parameters: Vz/F

    Time frame: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose

    Vz/F was defined as apparent volume of distribution.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, OPEN-LABEL, 3-TREATMENT, 6-SEQUENCE, 3-PERIOD CROSSOVER STUDY TO ESTIMATE THE EFFECT OF PF-07321332/RITONAVIR AND RITONAVIR ON THE PHARMACOKINETICS OF DABIGATRAN IN HEALTHY PARTICIPANTS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2021
Registry last updated
Mar 29, 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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