We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05064800
Recruitment Status : Completed
First Posted : October 1, 2021
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: Dabigatran Drug: PF-07321332/ritonavir + Dabigatran Drug: Ritonavir + Dabigatran Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a Phase1, 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
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : September 21, 2021
Actual Primary Completion Date : December 6, 2021
Actual Study Completion Date : December 6, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Treatment A
Dabigatran only
 Drug: Dabigatran
A single dose of Dabigatran on Day 1
Experimental: Treatment B
PF-07321332/ritonavir + Dabigatran
 Drug: PF-07321332/ritonavir + Dabigatran
PF-07321332/ritonavir twice daily (BID) for Days 1 and 2 Single dose of Dabigatran on Day 2
Active Comparator: Treatment C
Ritonavir + Dabigatran
 Drug: Ritonavir + Dabigatran
Ritonavir BID on Days 1 and 2 Single dose of Dabigatran on Day 2


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Area under the curve from time zero to infinity (AUCinf) of dabigatran when administer with PF-07321332/ritonavir [ Time Frame: Treatment A; pre-dose, and 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose ]
  2. Maximum Observed Plasma Concentration (Cmax) of dabigatran when administered with PF-07321332/ritonavir [ Time Frame: Treatment A; pre-dose, and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose ]

Secondary Outcome Measures :
  1. AUCinf of dabigatran when administered with multiple doses of ritonavir [ Time Frame: Treatment C; Pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose ]
  2. Cmax of dabigatran when administered with multiple doses of ritonavir [ Time Frame: Treatment C; pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose ]
  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Treatments A, B and C; through study completion of approximately 1.5 months ]
  4. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Treatments A, B, and C; through study completion of approximately 1.5 months ]
  5. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Treatment A, B, and C; through study completion of approximately 1.5 months ]
  6. Number of Participants With Abnormalities in Physical Examination [ Time Frame: Treatment A, B, and C; through study completion of approximately 1.5 months ]
  7. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings [ Time Frame: Treatment A, B, and C; through study completion of approximately 1.5 months ]
  8. Time to Reach Maximum Observed Plasma Concentration (Tmax) of dabigatran [ Time Frame: Treatments A, B and C; Pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours ]
  9. Plasma Decay Half-Life (t1/2) of dabigatran [ Time Frame: Treatments A, B and C; pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose ]
  10. Cmax of PF-07321332 [ Time Frame: Treatments A, B, C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose ]
  11. AUCtau (area under the curve of the dosing interval) of PF-0321332 [ Time Frame: Treatments A, B and C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose ]
  12. Tmax of PF-0321332 [ Time Frame: Treatments A, B and C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose ]
  13. T1/2 of PF-0321332 [ Time Frame: Treatments A, B and C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose ]
  14. Apparent Oral Clearance (CL/F) of PF-0321332 [ Time Frame: Treatments A, B and C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose ]
  15. Apparent Volume of Distribution (Vz/F) of PF-0321332 [ Time Frame: Treatments A, B and C: pre-dose and 1, 2, 4, 6, 8, 12, 16, 24, and 48 hours post-dose ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05064800


Locations
Layout table for location information
United States, Florida
Research Centers of America ( Hollywood )
Hollywood, Florida, United States, 33024
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05064800    
Other Study ID Numbers: C4671012
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Drug Drug Interaction
Dabigatran
P-gp Substrate
SARS-Co-V2
 COVID-19
protease inhibitor
ritonavir
Additional relevant MeSH terms:
Layout table for MeSH terms
Ritonavir
Nirmatrelvir
Dabigatran
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
 Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Anticoagulants