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A Study to Learn About How Different Forms of Study Medicine PF-07248144 Are Taken Up Into the Blood in Healthy Adults

Not Applicable
Completed
Conditions
Healthy Adults
Interventions
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
PF-07248144 Form 1 (uncoated) ArmPF-07248144Period 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 ArmPF-07248144Period 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) ArmPF-07248144Period 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
NameTimeMethod
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07248144 Form 1 uncoated tablet0 (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 tablet0 (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 tablet0 (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 tablet0 (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
NameTimeMethod
Number of Participants With Vital Signs Values Meeting Categorical Summarization CriteriaFrom Baseline up to Day 35
Number of Participants With Clinically Significant Physical Examination AbnormalitiesFrom Baseline up to Day 35
Number of Participants With Treatment Emergent Treatment Related AEs and SAEsFrom Baseline up to Day 35
Number of Participants With Laboratory Test AbnormalitiesFrom 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

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