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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Midazolam; Drug: PF-07941944; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06920498

C5961001

2024-515421-28-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Part 1

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-07941944

Part 2

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-07941944

Part 3 (Optional)

Experimental group

Description:

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

Treatment:

Drug: PF-07941944

Drug: Midazolam