A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma

NCT07660731 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: C66110012026-526260-21-00
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs)

  Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional)

  Parts A: Up to Day 36; Part B and E: Up to Day 50

• Number of Participants with Serious Adverse Events (SAEs)

  Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional)

  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

  Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional)

  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

  Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional).

  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

  Part A: Cohorts 1, 2 and Cohort 3 (optional). Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). Part E: Cohorts 11 (optional) and 12 (optional).

  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

  Part C: Cohort 9

  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

  Part C: Cohort 9

  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

  Part D: Cohort 10 (optional)

  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)

  Part F: Cohort 13 (optional)

  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

  Part F: Cohort 13 (optional)

  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)

Secondary Outcomes (34)

• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast)

  Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)

• Maximum observed plasma concentration (Cmax)

  Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)

• Time of Maximum observed plasma concentration (Tmax)

  Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)

• Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit

  Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)

• Half-life (t½) if data permit

  Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1 and at 24 and 36 hours post-dose (Day 2)

Study Arms (6)

Part A: Cohorts 1, 2 and Optional Cohort 3

PLACEBO COMPARATOR

PF-08103402 as suspension or matching placebo as a single oral dose on Day 1 of each period

Drug: PF-08103402; Drug: Placebo

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

PLACEBO COMPARATOR

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

Drug: PF-08103402; Drug: Placebo

Part C: Cohort 9

OTHER

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

Drug: PF-08103402

Part D: Cohort 10 (Optional)

OTHER

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

Drug: PF-08103402

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

PLACEBO COMPARATOR

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

Drug: PF-08103402; Drug: Placebo

Part F: Cohort 13 (Optional)

OTHER

Period 1: Single oral dose of midazolam on Day 1. Period 2: Once daily oral dose of PF-08103402 as suspension or tablet from Day 1 through Day 14 and a single oral dose of midazolam on Day 14.

Drug: PF-08103402; Drug: Midazolam

Interventions

PF-08103402 DRUG

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

Part A: Cohorts 1, 2 and Optional Cohort 3; Part B: Cohorts 4, 5, 6, 7, and Optional Cohort 8; Part C: Cohort 9; Part D: Cohort 10 (Optional); Part E: Cohorts 11 (Optional) and 12 (Optional); Part F: Cohort 13 (Optional)

Placebo DRUG

Oral suspension (Parts A, B and E).

Part A: Cohorts 1, 2 and Optional Cohort 3; Part B: Cohorts 4, 5, 6, 7, and Optional Cohort 8; Part E: Cohorts 11 (Optional) and 12 (Optional)

Midazolam DRUG

Oral syrup

Part F: Cohort 13 (Optional)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are 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 total body weight of more than 50 kilograms (110 pounds).
• For Part A (Optional group or cohort 3: Japanese participants only):
• A total body weight of more than 45 kg (100 pounds).
• Have 4 biological Japanese grandparents who were born in Japan.
• For Part E only:
• Adults with a documented doctor's-diagnosis history of asthma 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).

You may not qualify if:

• Evidence or history of clinically significant medical conditions.
• 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).
• History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
• Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
• Any history of parasitic infection requiring treatment within 28 days prior to screening.
• Positive tuberculosis infection test result.
• Part C only: Evidence or history of conditions interfering with the ability to taste.
• Part D only: History of irregular bowel movements.
• Part E only: Evidence of lung disease(s) other than asthma.
• Part E only: Asthma exacerbation within 3 months prior to screening.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Asthma

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Parts A, B, and E (Double-blind) Parts C, D, and F (Open-label)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Crossover design (Parts A, C \& F), Parallel design (Part B), Single period (Parts D \& E)

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 17, 2026
• Primary Completion (Estimated): June 18, 2027
• Study Completion (Estimated): June 18, 2027
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)