Skip to main content
OpenTrials
Completed

NCT Number: NCT06920498

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-07941944

Drug

Oral formulation

Placebo

Drug

Oral formulation

midazolam

Drug

Oral formulation

Primary outcomes

  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 1 and Part 2

  2. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 1 and Part 2

  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 1 and Part 2

  4. Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 1 and Part 2

  5. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 3

  6. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 3 - if data permit

  7. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 3 - If AUCinf not collected

Secondary outcomes

  1. Cmax

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 1 and Part 2

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 1 and Part 2

  3. AUClast

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 1 - if data permit

  4. AUCinf

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 1 - if data permit

  5. Plasma Decay Half-Life (t1/2)

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 1 and Part 2 - if data permit

  6. Area Under the Curve from Time Zero to end of dosing interval (AUCtau)

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 2

  7. Number of Participants With Treatment Emergent Treatment-Related AEs

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 3 - Optional

  8. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 3 - Optional

  9. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 3 - Optional

  10. Number of Participants With Change From Baseline in ECG Findings

    Time frame: Baseline through end of study, approximately 16 weeks

    Part 3 - Optional

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Multipart Phase 1 Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study With Single and Multiple Dose Escalation to Evaluate the Safety, Tolerability, and Pharmacokinetics of PF-07941944 in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.