A First-In-Human Study of the Study Medicine, Called PF-07291177, in Healthy Adult Participants

Phase 1

Withdrawn

• Conditions: Healthy Participants
• Interventions: Drug: PF-07291177; Drug: Placebo

• Registration Number: NCT05434091
• Lead Sponsor: Pfizer

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2022-06-22
• Study First Submitted QC: 2022-06-22
• Study First Posted: 2022-06-27
• Study Start: 2022-08-15
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-07
• Primary Completion: 2023-03-29
• Study Completion: 2023-03-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-07291177 and Placebo (Cohort 1)	PF-07291177	Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.
PF-07291177 and Placebo (Cohort 1)	Placebo	Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.
PF-07291177 and Placebo (Cohort 2)	Placebo	Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.
PF-07291177 and Placebo (Cohort 3)	PF-07291177	Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.
PF-07291177 and Placebo (Cohort 3)	Placebo	Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.
PF-07291177 and Placebo (Cohort 2)	PF-07291177	Single dose administration of PF-07291177 and placebo; Within a cohort, participants will receive 3 doses of PF-07291177 and 1 dose of placebo.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)	Baseline up to 35 days after last dose of study intervention (approximately 11 weeks)
Number of Participants With Clinical Laboratory Abnormalities	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	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	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	Baseline up to 10 days after last dose of study intervention (approximately 5 weeks)

Secondary Outcome Measures

Name	Time	Method
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
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
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