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NCT03806101

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

Completed Phase 1 Last updated 6 May 2019
What this trial tests

Phase 1 trial testing PF-04965842 in Healthy in 12 participants. Completed in 11 April 2019.

Timeline
23 January 2019
Primary endpoint
15 March 2019
11 April 2019

Quick facts

Lead sponsorPfizer
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment12
Start date23 January 2019
Primary completion15 March 2019
Estimated completion11 April 2019
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Evaluation of the Effect of Abrocitinib on Drug Transporters by Integrated Use of Probe Drugs and Endogenous Biomarkers.
    Vourvahis M, Byon W, Chang C, Le V, et al · · 2022 · cited 13× · PMID 35344588 · DOI 10.1002/cpt.2594

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