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Study of PF-04965842 Effect on Dabigatran Pharmacokinetics in Healthy Participants

NCT03742336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-02-28

No results posted yet for this study

Summary

This is a Phase 1, randomized, 2 way crossover, single dose, open label study of the effect of PF 04965842 on dabigatran PK in healthy participants. Participants will be randomized to 1 of 2 treatment sequences as described below. A total of 20 healthy male and/or female participants will be enrolled in the study so that 10 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods that are each 3 days in duration. The total duration of participation from the Screening Visit to Day 7 will be a maximum of 35 days and from the Screening Visit to Follow-up Contact/Visit will be a maximum of 70 days.

Conditions

  • Healthy

Interventions

DRUG

PF-04965842

Single oral 200 mg dose of PF-04965842

DRUG

Dabigatran

Single 75 mg dose of dabigatran

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-21
Primary Completion
2019-02-18
Completion
2019-02-18
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03742336 on ClinicalTrials.gov