Healthy Participants
Conditions
Keywords
Respiratory syncytial virus (RSV)
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.
Interventions
DRUGPF-07941944
Oral formulation
DRUGPlacebo
Oral formulation
DRUGMidazolam
Oral formulation
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Baseline through end of study, approximately 16 weeks | Part 3 - Optional |
| Cmax | Baseline through end of study, approximately 16 weeks | Part 1 and Part 2 |
| Number of Participants With Change From Baseline in ECG Findings | 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 |
| 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 |
Countries
Belgium
Outcome results
None listed