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

NCT06920498

CompletedPhase 1

Sponsor: Pfizer

Conditions: Healthy Participants

Interventions: PF-07941944, Placebo, Midazolam

Countries: Belgium

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Brussels, Bruxelles-capitale, Région de, Belgium