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

Официальное название

A PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, RELATIVE BIOAVAILABILITY, FOOD EFFECT, METABOLISM & EXCRETION, AND DRUG-DRUG INTERACTION POTENTIAL OF PF-08103402 IN HEALTHY ADULTS AND/OR ADULTS WITH MILD TO MODERATE ASTHMA

Обзор

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).

Вмешательства

• Препарат PF-08103402
  Oral suspension (Parts A to F); Tablets (Parts C and F only)
• Препарат Placebo
  Oral suspension (Parts A, B and E).
• Препарат Midazolam
  Oral syrup

Первичные конечные точки

• Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Parts A: Up to Day 36; Part B and E: Up to Day 50]
• Number of Participants with Serious Adverse Events (SAEs) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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)]

Вторичные конечные точки (12)

• Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Up to Day 36]
• Number of Participants With Serious Adverse Events (SAEs) [Срок оценки: Up to Day 36]
• Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [Срок оценки: Change From Baseline to Day 4]

Критерии участия

Key Inclusion criteria (Parts A, B, C, D and F):

• Are 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 total body weight of more than 50 kilograms (110 pounds).

For Part A (Optional group or cohort 3: Japanese participants only):

• A total body weight of more than 45 kg (100 pounds).
• 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).

Критерии исключения

• Evidence or history of clinically significant medical conditions.
• 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).
• History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
• Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
• Any history of parasitic infection requiring treatment within 28 days prior to screening.
• Positive tuberculosis infection test result.
• Part C only: Evidence or history of conditions interfering with the ability to taste.
• Part D only: History of irregular bowel movements.
• Part E only: Evidence of lung disease(s) other than asthma.
• Part E only: Asthma exacerbation within 3 months prior to screening.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Pfizer Clinical Research Unit - New Haven — New Haven

Идентификаторы

NCT: NCT07660731 · C6611001 · 2026-526260-21-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗