A PHASE 1, RANDOMIZED, OPEN-LABEL, CROSS-OVER, SINGLE DOSE STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF CANDIDATE CAPSULE FORMULATIONS OF PF-06651600 RELATIVE TO TABLETS IN HEALTHY PARTICIPANTS
Overview
- Phase
- Phase 1
- Intervention
- PF-06651600
- Conditions
- Healthy Volunteers
- Sponsor
- Pfizer
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The study will be conducted as a Phase 1, open-label, single dose, randomized, 4-period, cross over design in a single cohort of approximately 12 healthy male or female participants at a single center. Participants will be randomized into 1 of 4 sequences of treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment Sequence 1
Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment A); Period 2 (Treatment B); Period 3 (Treatment C); Period 4 (Treatment D).
Intervention: PF-06651600
Treatment Sequence 2
Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment B); Period 2 (Treatment D); Period 3 (Treatment A); Period 4 (Treatment C).
Intervention: PF-06651600
Treatment Sequence 3
Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment C); Period 2 (Treatment A); Period 3 (Treatment D); Period 4 (Treatment B).
Intervention: PF-06651600
Treatment Sequence 4
Participants will receive a single dose of each formulation of PF-06651600 in each period as follows: Period 1 (Treatment D); Period 2 (Treatment C); Period 3 (Treatment B); Period 4 (Treatment A).
Intervention: PF-06651600
Outcomes
Primary Outcomes
Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)of PF-06651600
Time Frame: Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.
Maximum plasma PF-06651600 concentration (C max)
Time Frame: Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.
Secondary Outcomes
- Single dose plasma decay half-life (t 1/2) of PF-06651600(Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.)
- Single dose Apparent Oral Clearance (CL/F) of PF-06651600(Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.)
- Single dose Apparent Volume of Distribution (Vz/F) of PF-06651600(Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.)
- Frequency of abnormal safety laboratory tests(Baseline up to day 9)
- Frequency of Adverse Events(Baseline up to Day 35)
- Single dose time to reach maximum observed plasma concentration (Tmax) of PF-06651600(Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.)
- Single dose Area under the Curve from Time Zero to Last quantifiable concentration [AUC last) of PF-06651600(Day 1 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 12, and 16 hrs, and Day 2, at 24 hours post-dose in Periods 1-4.)