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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-526260-21-00 | Registry Identifier | CTIS (EU) |
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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:
For Part A (optional group or cohort 3: Japanese participants only):
For Part E only:
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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. |
|
| Part C: Cohort 9 | Other | PF-08103402 as a single oral dose as suspensions or tablets on Day 1 of each period |
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| Part D: Cohort 10 (Optional) | Other | PF-08103402 as a single oral dose as suspension on Day 1. |
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| 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. |
|
| Part F: Cohort 13 (Optional) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-08103402 | Drug | Oral suspension (Parts A to F); Tablets (Parts C and F only) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) | Part A: Cohorts 1, 2 and Cohort 3 (optional). | 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) |
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Key Inclusion criteria (Parts A, B, C, D and F):
For Part A (Optional group or cohort 3: Japanese participants only):
For Part E only:
Adults with a documented doctor's-diagnosis history of asthma for at least 12 months before entering the study.
1. 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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - New Haven | Recruiting | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Crossover design (Parts A, C & F), Parallel design (Part B), Single period (Parts D & E)
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Parts A, B, and E (Double-blind) Parts C, D, and F (Open-label)
| 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. |
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| Placebo | Drug | Oral suspension (Parts A, B and E). |
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| Midazolam | Drug | Oral syrup |
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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) |
Part A: Cohorts 1, 2 and Cohort 3 (optional). |
| 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) | Part A: Cohorts 1, 2 and Cohort 3 (optional). | 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 | Part A: Cohorts 1, 2 and Cohort 3 (optional). | 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 | Part A: Cohorts 1, 2 and Cohort 3 (optional) | 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 over 1 dosing interval (AUCtau) | Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). | 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 |
| Maximum observed plasma concentration (Cmax) | Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). | 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 |
| Time of Maximum observed plasma concentration (Tmax) | Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). | 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 |
| Half-life (t½) if data permit | Part B: Cohorts 4, 5, 6, and 7 and Cohort 8 (optional). | 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 |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Part C: Cohort 9 | Up to Day 36 |
| Number of Participants With Serious Adverse Events (SAEs) | Part C: Cohort 9 | Up to Day 36 |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Part C: Cohort 9 | Change From Baseline to Day 4 |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Part C: Cohort 9 | Change From Baseline to Day 4 |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | Part C: Cohort 9 | Change From Baseline to Day 4 |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Part D: Cohort 10 (optional) | Up to Day 36 |
| Number of Participants With Serious Adverse Events (SAEs) | Part D: Cohort 10 (optional) | Up to Day 36 |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Part D: Cohort 10 (optional) | Change From Baseline to Day 11 |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Part D: Cohort 10 (optional) | Change From Baseline to Day 11 |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | Part D: Cohort 10 (optional) | Change From Baseline to Day 11 |
| Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise AUClast | Part D: Cohort 10 (optional) | 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) |
| Maximum observed plasma concentration (Cmax) | Part D: Cohort 10 (optional) | 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). |
| Change From Baseline (CFB) in Fractional concentration of exhaled Nitric Oxide (FeNO) at Day 14 | Part E: Cohorts 11 (optional) and 12 (optional) | 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) |
| Area under the curve over 1 dosing interval (AUCtau) | Part E: Cohorts 11 (optional) and 12 (optional) | 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) |
| Maximum observed plasma concentration (Cmax) | Part E: Cohorts 11 (optional) and 12 (optional) | 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) |
| Time of Maximum observed plasma concentration (Tmax) | Part E: Cohorts 11 (optional) and 12 (optional) | 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) |
| Half-life (t½) if data permit | Part E: Cohorts 11 (optional) and 12 (optional) | 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) |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Part F: Cohort 13 (optional) | Up to Day 51 |
| Number of Participants With Serious Adverse Events (SAEs) | Part F: Cohort 13 (optional) | Up to Day 51 |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Part F: Cohort 13 (optional) | Change From Baseline to Day 16 |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | Part F: Cohort 13 (optional) | Change From Baseline to Day 16 |
| Area under the curve over 1 dosing interval (AUCtau) | Part F: Cohort 13 (optional) | Pre-dose (Hour 0) and at 0.5, 1, 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, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1 (Period 1 ) and on Day 1 and Day 14 (Period 2) |
| Time of Maximum observed plasma concentration (Tmax) | Part F: Cohort 13 (optional) | Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1 (Period 1 ) and on Day 1 and Day 14 (Period 2) |
| Half-life (t½) if data permit | Part F: Cohort 13 (optional) | Pre-dose (Hour 0) and at 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose on Day 1 (Period 1 ) and on Day 1 and Day 14 (Period 2) |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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