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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.