A Study to Learn About How Different Forms of Study Medicine PF-07248144 Are Taken Up Into the Blood in Healthy Adults
- Registration Number
- NCT07117799
- Lead Sponsor
- Pfizer
- Brief Summary
Study has two arms. Arm 1 has two cohorts in which each cohort, under the fasted state, will either be given a single oral dose of Form 1 in Period 1 followed by a single oral dose of Form 5 in Period 2 or a single oral dose of Form 5 in Period 1 followed by a single oral dose of Form 1 in Period 2. A single oral dose of Form 1 will be administered in Arm 2 Period 1 under the fasted state. The results from Arm 1 will inform whether a different dose of Form 5 will be administered under the fasted state or if Form 5 will be administered under the fed state in Arm 2 Period 2.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PF-07248144 Form 1 (uncoated) Arm PF-07248144 Period 1: Participants received Form 1 in a single dose of tablet fasted Period 2: Participants received Form 5 in a single dose of tablet fasted PF-07248144 Form 5 (film-coated) Adaptive Arm PF-07248144 Period 1: Fasted participants received a single dose of tablet of Form 1 orally Period 2: Participants received a single dose of tablet orally of Form 5 in a fed state PF-07248144 Form 5 (film-coated) Arm PF-07248144 Period 1: Participants received Form 5 in a single dose of tablet fasted Period 2: Participants received Form 1 in a single dose of tablet fasted
- Primary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07248144 Form 1 uncoated tablet 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose AUCinf for PF-07248144 Form 5 film-coated tablet 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose Maximum Observed Plasma Concentration (Cmax) for PF-07248144 Form 1 uncoated tablet 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose Cmax for PF-07248144 Form 5 film-coated tablet 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose
- Secondary Outcome Measures
Name Time Method Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria From Baseline up to Day 35 Number of Participants With Clinically Significant Physical Examination Abnormalities From Baseline up to Day 35 Number of Participants With Treatment Emergent Treatment Related AEs and SAEs From Baseline up to Day 35 Number of Participants With Laboratory Test Abnormalities From Baseline up to Day 35
Trial Locations
- Locations (1)
Pfizer Clinical Research Unit - New Haven
🇺🇸New Haven, Connecticut, United States
Pfizer Clinical Research Unit - New Haven🇺🇸New Haven, Connecticut, United States