A Study to Learn How Different Amounts of the Study Medicine Called PF-07941944 Are Tolerated in the Body of Healthy Adults.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-03

Study Completion Date

2025-06-19

Brief Summary

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The purpose of this clinical trial is to learn about the safety and tolerability of the study medicine (called PF-07941944) in healthy participants.

This study is seeking participants who:

* Are male or female between the ages of 18 and 60
* Are generally healthy

The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help the investigators determine if the study medicine is safe and well tolerated.

Participants enrolled in Part 1 will take part in this study for approximately 4 months. Participants enrolled in Part 2 or Part 3 will take part in this study for approximately 2.5 months. Study visits will take place at the study clinic. The study team will also call participants once at the end of the study over the phone.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1

Single ascending dose of PF-07941944 or placebo in healthy adult participants

Group Type EXPERIMENTAL

PF-07941944

Intervention Type DRUG

Oral formulation

Placebo

Intervention Type DRUG

Oral formulation

Part 2

Multiple doses of PF-07941944 or placebo in healthy adult participants

Group Type EXPERIMENTAL

PF-07941944

Intervention Type DRUG

Oral formulation

Placebo

Intervention Type DRUG

Oral formulation

Part 3 (Optional)

Period 1, single dose of Midazolam. Period 2, multiple doses of PF-07941944 + Midazolam

Group Type EXPERIMENTAL

PF-07941944

Intervention Type DRUG

Oral formulation

Midazolam

Intervention Type DRUG

Oral formulation

Interventions

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PF-07941944

Oral formulation

Intervention Type DRUG

Placebo

Oral formulation

Intervention Type DRUG

Midazolam

Oral formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants who are overtly healthy as determined by medical evaluation
* Body mass index (BMI) of 17.5 to 30.5 kg/m2
* For inclusion of Japanese participants: participants who have 4 Japanese biologic grandparents who were born in Japan.

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
* Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
* Part 3 only: History of acute narrow-angle glaucoma, untreated open-angle glaucoma, sleep apnea, respiratory insufficiency, myasthenia gravis, or adverse reaction to midazolam or other benzodiazepines. History of hypersensitivity reaction to midazolam, or any of the formulation components.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes