A Study to Learn How Different Amounts of the Study Medicine Called PF-07941944 Are Tolerated in the Body of Healthy Adults.
- Conditions
- Healthy Participants
- Interventions
- Registration Number
- NCT06920498
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 66
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 PF-07941944 Single ascending dose of PF-07941944 or placebo in healthy adult participants Part 1 Placebo Single ascending dose of PF-07941944 or placebo in healthy adult participants Part 2 PF-07941944 Multiple doses of PF-07941944 or placebo in healthy adult participants Part 2 Placebo Multiple doses of PF-07941944 or placebo in healthy adult participants Part 3 (Optional) PF-07941944 Period 1, single dose of Midazolam. Period 2, multiple doses of PF-07941944 + Midazolam Part 3 (Optional) Midazolam Period 1, single dose of Midazolam. Period 2, multiple doses of PF-07941944 + Midazolam
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) Baseline through end of study, approximately 16 weeks Part 1 and Part 2
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities Baseline through end of study, approximately 16 weeks Part 1 and Part 2
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Baseline through end of study, approximately 16 weeks Part 1 and Part 2
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings Baseline through end of study, approximately 16 weeks Part 1 and Part 2
Maximum Observed Plasma Concentration (Cmax) Baseline through end of study, approximately 16 weeks Part 3
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) Baseline through end of study, approximately 16 weeks Part 3 - if data permit
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Baseline through end of study, approximately 16 weeks Part 3 - If AUCinf not collected
- Secondary Outcome Measures
Name Time Method Cmax Baseline through end of study, approximately 16 weeks Part 1 and Part 2
Time to Reach Maximum Observed Plasma Concentration (Tmax) Baseline through end of study, approximately 16 weeks Part 1 and Part 2
AUClast Baseline through end of study, approximately 16 weeks Part 1 - if data permit
AUCinf Baseline through end of study, approximately 16 weeks Part 1 - if data permit
Plasma Decay Half-Life (t1/2) Baseline through end of study, approximately 16 weeks Part 1 and Part 2 - if data permit
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) Baseline through end of study, approximately 16 weeks Part 2
Number of Participants With Treatment Emergent Treatment-Related AEs Baseline through end of study, approximately 16 weeks Part 3 - Optional
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities Baseline through end of study, approximately 16 weeks Part 3 - Optional
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Baseline through end of study, approximately 16 weeks Part 3 - Optional
Number of Participants With Change From Baseline in ECG Findings Baseline through end of study, approximately 16 weeks Part 3 - Optional
Related Research Topics
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Trial Locations
- Locations (1)
Pfizer Clinical Research Unit - Brussels
🇧🇪Brussels, Bruxelles-capitale, Région DE, Belgium