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

NCT03806101 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-05-06

No results posted yet for this study

Summary

This is a Phase 1, randomized, 2 way crossover, multiple dose, open label study of the effect of PF 04965842 on rosuvastatin PK in healthy participants. Participants will be randomized to 1 of the 2 treatment sequences. A total of approximately 12 healthy male and/or female participants will be enrolled in the study so that approximately 6 participants will be enrolled in each treatment sequence. Each treatment sequence will consist of 2 periods. In both sequences, participants will remain in the CRU for a total of 11 days and 10 nights (including Period 1 and Period 2). To adequately remove any drug effects of rosuvastatin from Period 1 to Period 2, there will be a minimum 5 day washout period between the 2 rosuvastatin dosing events.

Conditions

  • Healthy

Interventions

DRUG

PF-04965842

200 mg dose of PF-04965842 once daily (QD) for 3 days

DRUG

Rosuvastatin

Single 10 mg dose of rosuvastatin

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
2019-01-23
Primary Completion
2019-03-15
Completion
2019-04-11
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 NCT03806101 on ClinicalTrials.gov