Recruiting
Phase 1

PF-08103402

Sponsor:

Pfizer

Code:

NCT07660731

Conditions

Healthy Volunteer Study

Healthy Adults

Healthy Participants

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

PF-08103402

Placebo

Midazolam

Study Details

Brief summary:

The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people.

For Parts A, B, C, D and F, the study is seeking participants who:

  • Are healthy (do not have disease) males or females who can no longer have children,
  • Are 18 to 65 years old,
  • Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a body weight of more than 50 kilograms (110 pounds). Body mass index is a way to measure body fat by using a person's height and weight

For Part A (optional group or cohort 3: Japanese participants only):

  • A body weight of more than 45 kilograms (100 pounds).
  • Have 4 biological Japanese grandparents who were born in Japan.

For Part E only:

  • Adults with a documented history of asthma (confirmed by a doctor) for at least 12 months before entering the study.
  • Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).

The study has six parts: Part A, Part B, Part C, Part D, Part E and Part F. The study medicine will be taken as a suspension or tablet by mouth 1 time a day (except in Parts B and E where it will be taken 1 time a day for 14 days) at the study clinic. The study will help understand:

  • how the body processes the study medicine in healthy participants (Parts A and B),
  • how much of the study medicine gets into the bloodstream and if food affects the amount of study medicine in the blood in healthy participants (Part C),
  • how the study medicine is broken down and leaves the body in healthy participants (Optional Part D),
  • how the study medicine is processed in adults with mild-to-moderate asthma (Optional Part E),
  • if taking the study medicine together with another medicine affects how each medicine is processed by the body in healthy participants (Optional Part F).

Participants will take part in the study for about 10 weeks (Parts A and F), 12 weeks (Part B), 9 weeks (Parts C and D), and 16 weeks (Part E).

During this time, they will have 2 study visits at the study clinic and up to 28 overnight stays (Part A), 18 overnight stays (Parts B and E), 10 overnight stays (Part C), 11 overnight stays (Part D), and 16 overnight stays (Part F). The study team will also call participants 1 time over the phone at the end of the study to assess how they are doing.

Study measurements will be taken by body examination, monitoring side effects, blood and urine tests, heart tests (ECG), vital signs (blood pressure and pulse), questionnaires (Parts C and E), stool samples (Part D only), and breathing tests (Part E only).

Conditions

Healthy Volunteer Study

Healthy Adults

Healthy Participants

Asthma

Study ID

NCT07660731

Start date

Jun 17, 2026

Status verified date

Aug, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Key Inclusion criteria (Parts A, B, C, D and F):

1. Are males or females who can no longer have children,
2. Are 18 to 65 years old,
3. Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).

For Part A (Optional group or cohort 3: Japanese participants only):

1. A total body weight of more than 45 kg (100 pounds).
2. Have 4 biological Japanese grandparents who were born in Japan.

For Part E only:

1. Adults with a documented doctor's-diagnosis history of asthma for at least 12 months before entering the study.
2. Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).

Key Exclusion criteria

1. Evidence or history of clinically significant medical conditions.
2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).
3. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
5. Any history of parasitic infection requiring treatment within 28 days prior to screening.
6. Positive tuberculosis infection test result.
7. Part C only: Evidence or history of conditions interfering with the ability to taste.
8. Part D only: History of irregular bowel movements.
9. Part E only: Evidence of lung disease(s) other than asthma.
10. Part E only: Asthma exacerbation within 3 months prior to screening.
11. Part F 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.

Study Design

Enrollment

133 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Part F: Cohort 13 (Optional)

Period 1: Single oral dose of midazolam on Day 1. Period 2: Once daily oral dose of PF-08103402 as tablets from Day 1 through Day 14 and a single oral dose of midazolam on Day 14 after the administration of PF-08103402.

placebo comparator: Part B: Cohorts 4, 5, 6, 7, and Optional Cohort 8

PF-08103402 as tablets or matching placebo given once daily oral doses from Day 1 through Day 14.

placebo comparator: Part A: Cohorts 1, 2 and Optional Cohort 3

PF-08103402 as suspensions (Cohorts 1 and 2)/tablets (Optional Cohort 3) or matching placebo as a single oral dose on Day 1 of each period

placebo comparator: Part E: Cohorts 11 (Optional) and 12 (Optional)

PF-08103402 as tablets or corresponding placebo as oral doses from Day 1 through Day 14.

other: Part D: Cohort 10 (Optional)

PF-08103402 as a single oral dose as tablets on Day 1.

other: Part C: Cohort 9

PF-08103402 as a single oral dose as tablets on Day 1 of each period

Interventions

PF-08103402

Oral suspension (Parts A to F); Tablets (Parts C and F only)

Placebo

Oral suspension (Parts A, B and E).

Midazolam

Oral syrup

Primary outcome measure

  • Number of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Parts A: Up to Day 36; Part B and E: Up to Day 50 ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Parts A: Up to Day 36; Part B and E: Up to Day 50 ]
  • Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17 ]
  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17 ]
  • Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings [ Time Frame: Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17 ]
  • Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise (AUClast) in the fasted state [ Time Frame: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 ]
  • Maximum observed plasma concentration (Cmax) in the fasted state [ Time Frame: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 ]
  • Total recovery of drug-related material in urine and feces separately, and both routes combined, expressed as a percent of total dose administered [ Time Frame: Pre-dose (Hour 0) and at 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2) ]
  • Maximum observed plasma concentration (Cmax) [ Time Frame: Pre-dose (Hour 0) and at 0.5, 1, 2, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2) ]
  • Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise AUClast [ Time Frame: Pre-dose (Hour 0) and at 0.5, 1, 2, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 hours post-dose (Day 2) ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

1-800-718-1021ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Pfizer Clinical Research Unit - New Haven

Recruiting

New Haven, Connecticut, United States, 06511

More Information

Sponsor

Pfizer

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Human
  • Randomized
  • Metabolism
  • Excretion
  • Drug-Drug Interaction
  • Food effect

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pfizer on 2026-09-02.