A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO CONTROLLED, 4-PERIOD, CROSSOVER, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SINGLE ASCENDING ORAL DOSES OF PF 07291177 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Pfizer
- Primary Endpoint
- Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Study Overview
Brief Summary
The purpose of the study is to learn about the safety, tolerability (the extent to which side effects can be tolerated), and plasma pharmacokinetics (PK) (PK helps us understand how the drug is changed and eliminated from body after you take it) of PF-07291177 after administration of escalating, single, doses by mouth.
Detailed Description
The purpose of the study is to learn about the safety, the extent to which side effects can be tolerated, and plasma pharmacokinetics (PK) (PK helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07291177 after administration of escalating, single, doses by mouth.
Each participant in this study is planned to undergo up to 4 treatment periods receiving up to 3 doses of PF 07291177 and 1 dose of placebo.
Precautionary sentinel dosing will be used in this study. Two participants (1 receiving PF 07291177 and 1 receiving placebo) within a period will be dosed initially before the remaining participants of that period are dosed.
This study is seeking :
- Female participants of non-child bearing potential and males must be 18 to 60 years of age, inclusive, at the time of signing the ICD
- Female participants of non-child bearing potential and males who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PF-07291177 and Placebo (Cohort 1)
Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.
Intervention: PF-07291177 (Drug)
PF-07291177 and Placebo (Cohort 1)
Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.
Intervention: Placebo (Drug)
PF-07291177 and Placebo (Cohort 2)
Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.
Intervention: PF-07291177 (Drug)
PF-07291177 and Placebo (Cohort 2)
Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.
Intervention: Placebo (Drug)
PF-07291177 and Placebo (Cohort 3)
Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.
Intervention: PF-07291177 (Drug)
PF-07291177 and Placebo (Cohort 3)
Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time Frame: Baseline up to 35 days after last dose of study intervention (approximately 11 weeks)
Number of Participants With Clinical Laboratory Abnormalities
Time Frame: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings
Time Frame: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time Frame: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Number of Participants With Clinically-Significant Change From Baseline in Neurological Examination Findings
Time Frame: Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)
Secondary Outcomes
- Plasma Half-Life (t1/2) of PF-07291177(Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period)
- Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07291177(Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07291177(Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period)
- Maximum Observed Plasma Concentration (Cmax) of PF-07291177(Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period)
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07291177(Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 post-dose in each period)