RightFit
RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 2 visits
  • Time periods mentioned: 10 weeks
  • Procedures mentioned: Urine samples, Heart tracing (ECG), Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of different amounts of PF-08103402 and how the body handles it. It is for healthy adults or adults with mild-to-moderate asthma. This is the first time this study medicine is being given to people.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Parts A, B, C, D and F: Be healthy and 18 to 65 years old.
  • Parts A, B, C, D and F: Be male, or be female and no longer able to have children.
  • Parts A, B, C, D and F: Have a BMI of 16 to 32 and weigh more than 50 kg (110 pounds). BMI is a measure based on height and weight.
  • Optional Japanese group in Part A: Weigh more than 45 kg (100 pounds).
  • Optional Japanese group in Part A: Have 4 biological Japanese grandparents who were born in Japan.
  • Part E: Be an adult with asthma diagnosed by a doctor at least 12 months before joining.
  • Part E: Have a BMI of 16 to 35 and weigh more than 50 kg (110 pounds).

Who can't join

  • Have or have had a major medical condition.
  • Have a history of HIV, hepatitis B or hepatitis C, or a positive test for any of these infections. A positive test for tuberculosis (TB) also rules you out.
  • Have had alcohol abuse, binge drinking, illegal drug use or drug dependence within 6 months before screening.
  • Take part in another study of an experimental drug or vaccine while in this study.
  • Have had a parasite infection needing treatment within 28 days before screening.
  • Part C: Have or have had a condition that affects taste. Part D: Have a history of irregular bowel movements.
  • Part E: Have a lung disease other than asthma, or have had an asthma flare-up within 3 months before screening.
  • Part F: Have a history of certain types of glaucoma (an eye disease): acute narrow-angle or untreated open-angle glaucoma; sleep apnea (breathing pauses during sleep); trouble breathing well enough; myasthenia gravis (a disease that weakens muscles); or a bad reaction to midazolam or other benzodiazepines (sedative medicines).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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: 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.

Study sites (1)

CT