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

Phase 1RecruitingNCT07660731

Pfizer133 enrolled

Overview

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).

Study Type

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Interventions

PF-08103402DRUG

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

PlaceboDRUG

Oral suspension (Parts A, B and E).

MidazolamDRUG

Oral syrup

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 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)

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

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)

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

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).

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

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).

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

Part C: Cohort 9

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

Part C: Cohort 9

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

Part D: Cohort 10 (optional)

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)

Part F: Cohort 13 (optional)

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

Part F: Cohort 13 (optional)

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)

Secondary Outcomes

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).

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 and at 24 and 36 hours post-dose (Day 2)

Maximum observed plasma concentration (Cmax)

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

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 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).

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 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).

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 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)

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 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).

Time frame: 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).

Time frame: 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

Central Contacts

Pfizer CT.gov Call Center

CONTACT

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time of Maximum observed plasma concentration (Tmax)

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

Time frame: 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).

Time frame: 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

Time frame: Up to Day 36

Number of Participants With Serious Adverse Events (SAEs)

Part C: Cohort 9

Time frame: Up to Day 36

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

Part C: Cohort 9

Time frame: Change From Baseline to Day 4

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

Part C: Cohort 9

Time frame: Change From Baseline to Day 4

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

Part C: Cohort 9

Time frame: Change From Baseline to Day 4

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Part D: Cohort 10 (optional)

Time frame: Up to Day 36

Number of Participants With Serious Adverse Events (SAEs)

Part D: Cohort 10 (optional)

Time frame: Up to Day 36

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

Part D: Cohort 10 (optional)

Time frame: Change From Baseline to Day 11

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

Part D: Cohort 10 (optional)

Time frame: Change From Baseline to Day 11

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

Part D: Cohort 10 (optional)

Time frame: 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)

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, 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)

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

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

Time frame: 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)

Time frame: 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)

Time of Maximum observed plasma concentration (Tmax)

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

Half-life (t½) if data permit

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

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Part F: Cohort 13 (optional)

Time frame: Up to Day 51

Number of Participants With Serious Adverse Events (SAEs)

Part F: Cohort 13 (optional)

Time frame: Up to Day 51

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

Part F: Cohort 13 (optional)

Time frame: Change From Baseline to Day 16

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

Part F: Cohort 13 (optional)

Time frame: Change From Baseline to Day 16

Area under the curve over 1 dosing interval (AUCtau)

Part F: Cohort 13 (optional)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts