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
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
133
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Lead sponsor
Pfizer
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Start date
2026-06-17
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Number of sites
1
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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, pulse and respiratory rate), questionnaires (Parts C and E), stool samples (Part D only), and breathing tests (Part E only).
clinicaltrials.gov
Short title
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
clinicaltrials.gov
Official title
A PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, FOOD EFFECT, METABOLISM & EXCRETION, AND DRUG-DRUG INTERACTION POTENTIAL OF PF-08103402 IN HEALTHY ADULTS AND/OR ADULTS WITH MILD TO MODERATE ASTHMA
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-03-30
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First posted
2026-06-22
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Registry last updated
2026-10-13
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Primary completion date
2027-03-30
clinicaltrials.gov
Start date
2026-06-17
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Participants
133
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Participant count basis
Estimated
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Planned participants
133
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Protocol amendments
3
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07660731
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ClinicalTrials.gov ID
NCT07660731
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Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Sequential
Purpose
Basic science
Masking
Double masking
Masking description
Parts A, B, and E (Double-blind) Parts C, D, and F (Open-label)
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

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

    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)

  2. Number of Participants with Serious Adverse Events (SAEs)

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

    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)

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

    Timeframe: Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17

    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)

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

    Timeframe: Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17

    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).

  5. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

    Timeframe: Parts A: Change From Baseline to Day 7; Part B and E: Change From Baseline to Day 17

    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).

  6. Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise (AUClast) in the fasted state

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

    Part C: Cohort 9

  7. Maximum observed plasma concentration (Cmax) in the fasted state

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

    Part C: Cohort 9

  8. Total recovery of drug-related material in urine and feces separately, and both routes combined, expressed as a percent of total dose administered

    Timeframe: 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)

    Part D: Cohort 10 (optional)

  9. Maximum observed plasma concentration (Cmax)

    Timeframe: 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)

    Part F: Cohort 13 (optional)

  10. Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise AUClast

    Timeframe: 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)

    Part F: Cohort 13 (optional)

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

    Timeframe: 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)

    Part A: Cohorts 1, 2 and Cohort 3 (optional).

  2. Maximum observed plasma concentration (Cmax)

    Timeframe: 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)

    Part A: Cohorts 1, 2 and Cohort 3 (optional).

  3. Time of Maximum observed plasma concentration (Tmax)

    Timeframe: 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)

    Part A: Cohorts 1, 2 and Cohort 3 (optional).

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

    Timeframe: 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)

    Part A: Cohorts 1, 2 and Cohort 3 (optional).

  5. Half-life (t½) if data permit

    Timeframe: 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)

    Part A: Cohorts 1, 2 and Cohort 3 (optional)

  6. Area under the curve over 1 dosing interval (AUCtau)

    Timeframe: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14

    Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).

  7. Maximum observed plasma concentration (Cmax)

    Timeframe: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14

    Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).

  8. Time of Maximum observed plasma concentration (Tmax)

    Timeframe: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14

    Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).

  9. Half-life (t½) if data permit

    Timeframe: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1, Day 7 and Day 14

    Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional).

  10. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to Day 36

    Part C: Cohort 9

  11. Number of Participants With Serious Adverse Events (SAEs)

    Timeframe: Up to Day 36

    Part C: Cohort 9

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

    Timeframe: Change From Baseline to Day 4

    Part C: Cohort 9

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

    Timeframe: Change From Baseline to Day 4

    Part C: Cohort 9

  14. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

    Timeframe: Change From Baseline to Day 4

    Part C: Cohort 9

  15. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to Day 36

    Part D: Cohort 10 (optional)

  16. Number of Participants With Serious Adverse Events (SAEs)

    Timeframe: Up to Day 36

    Part D: Cohort 10 (optional)

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

    Timeframe: Change From Baseline to Day 11

    Part D: Cohort 10 (optional)

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

    Timeframe: Change From Baseline to Day 11

    Part D: Cohort 10 (optional)

  19. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings

    Timeframe: Change From Baseline to Day 11

    Part D: Cohort 10 (optional)

  20. Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise AUClast

    Timeframe: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1, 24 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6), 144 hours post-dose (Day 7)

    Part D: Cohort 10 (optional)

  21. Maximum observed plasma concentration (Cmax)

    Timeframe: Pre-dose (Hour 0) and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose on Day 1, 24 hours post-dose (Day 2), 48 hours post-dose (Day 3), 72 hours post-dose (Day 4), 96 hours post-dose (Day 5), 120 hours post-dose (Day 6), 144 hours post-dose (Day 7).

    Part D: Cohort 10 (optional)

  22. Change From Baseline (CFB) in Fractional concentration of exhaled Nitric Oxide (FeNO) at Day 14

    Timeframe: Pre-dose (Hour 0) and at 72 hours post-dose (Day 4), 144 hours post-dose (Day 7), 264 hours post-dose (Day 12), 312 hours post-dose (Day 14) and 384 hours post-dose (Day 17)

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

  23. Area under the curve over 1 dosing interval (AUCtau)

    Timeframe: Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)

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

  24. Maximum observed plasma concentration (Cmax)

    Timeframe: Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)

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

  25. Time of Maximum observed plasma concentration (Tmax)

    Timeframe: Pre-dose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose (Day 1); 24 hours post-dose (Day 2); 144 hours post-dose (Day 7); 312 hours post-dose (Day 14); 336 hours post-dose (Day 15); 360 hours post-dose (Day 16); 384 hours post-dose (Day 17)

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

And 9 more, listed on the interactive page.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
Yes

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.
Sources for eligibility
clinicaltrials.gov

  • Pfizer Clinical Research Unit - New HavenNew Haven, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2026-526260-21-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (16)