drugset / Trial / NCT03230383

A Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects

NCT03230383

Phase 1 Completed 60 enrolled Pfizer
RandomizedSequentialDouble-blindBasic science

Summary

This will be an investigator- and subject-blinded (sponsor open), randomized, placebo controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts), and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10 subjects dosed in each cohort. For a given subject in any cohort, the total study duration from screening to follow-up phone call will be between approximately 7 to 11 weeks.

Timeline

Start
2017-08-01
Primary completion
2018-05-03
Completion
2018-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject PF-06865571 Small molecule 90 mg Oral
Subject PF-06865571 Small molecule 300 mg Oral
Subject PF-06865571 Small molecule 900 mg Oral
Subject PF-06865571 Small molecule 1800 mg Oral
Subject PF-06865571 Small molecule 3000 mg Oral

Indications

No indication recorded.