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

Pfizer

Status and phase: Not yet enrolling; Phase 1

Conditions: Asthma; Healthy Adults; Healthy Participants; Healthy Volunteer Study

Treatments: Drug: Midazolam; Drug: Placebo; Drug: PF-08103402

Study type: Interventional

Funder types: Industry

Identifiers

NCT07660731

C6611001

Details and patient eligibility

About

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).

Enrollment: 139 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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:

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

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

139 participants in 6 patient groups, including a placebo group

Part A: Cohorts 1, 2 and Optional Cohort 3

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-08103402

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

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-08103402

Part C: Cohort 9

Other group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-08103402

Part D: Cohort 10 (Optional)

Other group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-08103402

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

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: PF-08103402

Part F: Cohort 13 (Optional)

Other group

Description:

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.

Treatment:

Drug: Placebo

Drug: PF-08103402

Drug: Midazolam