Healthy ParticipantsPhase 1NCT05064800

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

A Phase 1 study testing Dabigatran, PF-07321332/ritonavir + Dabigatran and Ritonavir + Dabigatran in people with Healthy Participants, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Dabigatran, PF-07321332/ritonavir + Dabigatran and Ritonavir + Dabigatran
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 21 Sep 2021to 6 Dec 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Centers of America ( Hollywood )
Hollywood, Florida, 33024

Other trials in United States

About this study

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

Conditions: Healthy Participants
Being tested: Dabigatran, PF-07321332/ritonavir + Dabigatran, Ritonavir + Dabigatran
Keywords: Drug Drug Interaction, Dabigatran, P-gp Substrate, SARS-Co-V2, COVID-19, protease inhibitor, ritonavir
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05064800
Study group	Role	What they receive
Treatment A	Active comparator	Dabigatran only Receives: Drug: Dabigatran
Treatment B	Experimental	PF-07321332/ritonavir + Dabigatran Receives: Drug: PF-07321332/ritonavir + Dabigatran
Treatment C	Active comparator	Ritonavir + Dabigatran Receives: Drug: Ritonavir + Dabigatran

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Maximum Plasma Concentration (Cmax)
Cmax was defined as maximum observed plasma concentration.
Measured: 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
Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUCinf
AUCinf was defined as the area under the plasma concentration-time curve from time 0 extrapolated to infinity
Measured: 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
Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): AUClast
AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration.
Measured: 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

Secondary outcomes (17)

Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Maximum Plasma Concentration (Cmax)
Cmax was defined as maximum observed plasma concentration
Measured: 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
Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUCinf
AUCinf was defined as area under the plasma concentration-time curve from time 0 extrapolated to infinity
Measured: 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
Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): AUClast
AUClast was defined as area under the plasma concentration time curve from time 0 to the time of the last measurable concentration.
Measured: 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
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs , and TEAEs Leading to Participant Discontinuation From Study
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.
Measured: From Pre-dose on Day 1 to Day 48
Number of Participants With Laboratory Test Abnormality (Without Regard to Baseline Abnormality)
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.
Measured: From pre-dose on Day 1 to Day 3
Number of Participants With Vital Signs of Potential Clinical Concern
Single supine blood pressure and pulse rate tests were assessed against the criteria specified in the sponsor reporting standards.
Measured: From pre-dose on Day 1 to Day 3
Number of Participants With ECG Values of Potential Clinical Concern
QT interval, QTc, PR, RR, QRS and heart rate tests were assessed against the criteria specified in the sponsor reporting standards.
Measured: From pre-dose on Day 1 to Day 3
Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Time to First Occurrence of Cmax (Tmax)
Tmax was defined as time to first occurrence of Cmax
Measured: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): Tmax
Tmax was defined as time to first occurrence of Cmax.
Measured: Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Plasma Dabigatran (Total) PK Parameters (PF-07321332/Ritonavir Co-administered With Dabigatran [Treatment 2]): Terminal Half-life (t½)
t½ was defined as terminal half-life of Dabigatran (Total) PK Parameters (PF-07321332/ritonavir co-administered with dabigatran.
Measured: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Plasma Dabigatran (Total) PK Parameters (Ritonavir Co-administered With Dabigatran [Treatment 3]): t½
t½ was defined as terminal half-life of Dabigatran (Total).
Measured: Treatment 3 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose
Plasma PF-07321332 PK Parameters: Cmax
Measured: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose
Plasma PF-07321332 PK Parameters: AUCtau
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.
Measured: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose
Plasma PF-07321332 PK Parameters: t½
t½ was defined as terminal half-life of PF-07321332.
Measured: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose
Plasma PF-07321332 PK Parameters: Tmax
Tmax was defined as time to first occurrence of Cmax.
Measured: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose
Plasma PF-07321332 PK Parameters: CL/F
CL/F was defined as apparent clearance of drug from plasma.
Measured: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose
Plasma PF-07321332 PK Parameters: Vz/F
Vz/F was defined as apparent volume of distribution.
Measured: Treatment 2 Day 2 pre-dose, and at 1, 2, 4, 6, 8, 12 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Sep 20216 Dec 2021

First posted1 Oct 2021
Study start21 Sep 2021
Primary completion6 Dec 2021
Study completion6 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
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)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05064800
Sponsor's protocol ID: C4671012
Status last verified: Oct 2023
First submitted: 1 Sep 2021
Last updated: 29 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

Cox DS, Rehman M, Khan T, Ginman K, Salageanu J, LaBadie RR, Wan K, Damle B. Effects of nirmatrelvir/ritonavir on midazolam and dabigatran pharmacokinetics in healthy participants. Br J Clin Pharmacol. 2023 Nov;89(11):3352-3363. doi: 10.1111/bcp.15835. Epub 2023 Jul 12.
PubMed 37354048
Sagawa K, Lin J, Jaini R, Di L. Physiologically-Based Pharmacokinetic Modeling of PAXLOVID with First-Order Absorption Kinetics. Pharm Res. 2023 Aug;40(8):1927-1938. doi: 10.1007/s11095-023-03538-5. Epub 2023 May 25.
PubMed 37231296

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05064800
Acronym / sponsor ID: C4671012
Conditions: Healthy Participants
Keywords: Drug Drug Interaction, Dabigatran, P-gp Substrate, SARS-Co-V2, COVID-19, protease inhibitor, ritonavir
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 21 Sep 2021 (actual)
Primary completion: 6 Dec 2021 (actual)
Study completion: 6 Dec 2021 (actual)
First posted: 1 Oct 2021 (actual)
Results: Posted 29 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3
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

Arm	Type	Receives
Treatment A	Active comparator	Drug: DabigatranDabigatran only
Treatment B	Experimental	Drug: PF-07321332/ritonavir + DabigatranPF-07321332/ritonavir + Dabigatran
Treatment C	Active comparator	Drug: Ritonavir + DabigatranRitonavir + Dabigatran

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DabigatranA single dose of Dabigatran on Day 1	Drug	Treatment A
PF-07321332/ritonavir + DabigatranPF-07321332/ritonavir twice daily (BID) for Days 1 and 2 Single dose of Dabigatran on Day 2	Drug	Treatment B
Ritonavir + DabigatranRitonavir BID on Days 1 and 2 Single dose of Dabigatran on Day 2	Drug	Treatment C

Primary outcome

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.
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
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.

17 secondary outcomes

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
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
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
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
Number of Participants With Laboratory Test Abnormality (Without Regard to Baseline Abnormality)
Time frame: From pre-dose on Day 1 to Day 3
Number of Participants With Vital Signs of Potential Clinical Concern
Time frame: From pre-dose on Day 1 to Day 3
Number of Participants With ECG Values of Potential Clinical Concern
Time frame: From pre-dose on Day 1 to Day 3
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
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
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
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
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
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
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
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
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
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

Results and safety

Results posted to the registry on 29 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran 75mg=>PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg=>Ritonavir 100mg+Dabigatran 75mg	4	4
Dabigatran 75mg=>Ritonavir 100mg+Dabigatran 75mg=>PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg	4	4
PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg=>Dabigatran 75mg=>Ritonavir 100mg+Dabigatran 75mg	4	4
PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg=>Ritonavir 100mg+Dabigatran 75mg=>Dabigatran 75mg	4	4
Ritonavir 100mg+Dabigatran 75mg=>Dabigatran 75mg=>PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg	4	4
Ritonavir 100mg+Dabigatran 75mg=>PF-07321332 300mg+Ritonavir 100mg+Dabigatran 75mg=>Dabigatran 75mg	4	4

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Treatment 1: Dabigatran 75 mg n = 24	Treatment 2: PF-07321332 300 mg + Ritonavir 100 mg + Dabigatran 75 mg n = 24
Value	71.87 (78)	154.1 (72)

Treatment 1: Dabigatran 75 mg vs Treatment 2: PF-07321332 300 mg + Ritonavir 100 mg + Dabigatran 75 mg: Ratio of Adjusted Geometric Means: 233.06 (90% CI 172.14 to 315.54), Mixed Models Analysis

Population analysed: All participants assigned to investigational product and treated who have at least 1 concentration measured.

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

Measure	Treatment 1: Dabigatran 75 mg n = 24	Treatment 2: PF-07321332 300 mg + Ritonavir 100 mg + Dabigatran 75 mg n = 24
Value	625.6 (61)	1177 (66)

Treatment 1: Dabigatran 75 mg vs Treatment 2: PF-07321332 300 mg + Ritonavir 100 mg + Dabigatran 75 mg: Ratio of Adjusted Geometric Means: 169.07 (90% CI 135.25 to 211.35), Mixed Models Analysis

Population analysed: All participants assigned to investigational product and treated who have at least 1 concentration measured.

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

Measure	Treatment 1: Dabigatran 75 mg n = 24	Treatment 2: PF-07321332 300 mg + Ritonavir 100 mg + Dabigatran 75 mg n = 24
Value	595.0 (65)	1178 (68)

Treatment 1: Dabigatran 75 mg vs Treatment 2: PF-07321332 300 mg + Ritonavir 100 mg + Dabigatran 75 mg: Ratio of Adjusted Geometric Means: 160.05 (90% CI 119.19 to 214.90), Mixed Models Analysis

Population analysed: All participants assigned to investigational product and treated who have at least 1 concentration measured.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Study Day 1 up to Study Day 48. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment 1: Dabigatran 75 mg	0 of 24 (0%)	0 of 24 (0%)	0 of 24
Treatment 2: PF-07321332 300 mg + Ritonavir 100 mg + Dabigatran 75 mg	0 of 24 (0%)	1 of 24 (4.2%)	0 of 24
Treatment 3: Ritonavir 100 mg + Dabigatran 75 mg	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37354048Cox DS, Rehman M, Khan T, Ginman K, Salageanu J, LaBadie RR, Wan K, Damle B. Effects of nirmatrelvir/ritonavir on midazolam and dabigatran pharmacokinetics in healthy participants. Br J Clin Pharmacol. 2023 Nov;89(11):3352-3363. doi: 10.1111/bcp.15835. Epub 2023 Jul 12.
Derived from this study: PubMed 37231296Sagawa K, Lin J, Jaini R, Di L. Physiologically-Based Pharmacokinetic Modeling of PAXLOVID with First-Order Absorption Kinetics. Pharm Res. 2023 Aug;40(8):1927-1938. doi: 10.1007/s11095-023-03538-5. Epub 2023 May 25.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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.

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A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dabigatran, PF-07321332/ritonavir + Dabigatran and Ritonavir + Dabigatran in people with Healthy Participants, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05064800, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.