Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics(PK) of PF-06865571
NCT03092232 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2017-08-14
Summary
The current study is the first clinical trial proposed with PF-06865571. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single doses of PF-06865571 to healthy adult subjects.
Conditions
- Healthy
Interventions
- DRUG
-
PF-06865571
Single ascending dose of PF-06865571 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 5 mg, 50 mg, 500 mg, TBD (to be determined)/2000 mg.
- DRUG
-
PF-06865571
Single ascending dose of PF-06865571 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 15 mg, 150 mg, 1000 mg, TBD/2000 mg.
- DRUG
-
PF-06865571
Single repeated (TBD mg) dose as extemporaneously prepared solution/suspension of PF-06865571.
- DRUG
-
Matching Placebo for PF-06865571 for each cohort.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-03-16
- Primary Completion
- 2017-07-13
- Completion
- 2017-07-17
- FDA Drug
- Yes
Countries
- United States
Study Locations
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