A PHASE 1, RANDOMIZED, DOUBLE-BLIND (SPONSOR-OPEN) PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFECT OF PF-07293893 ON SKELETAL MUSCLE BIOMARKERS IN HEALTHY ADULT PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Change from baseline of skeletal muscle pACC/tACC ratio
研究概览
简要总结
The purpose of this study is to understand how the study medicine (PF-07293893) affects muscle biomarkers. Biomarkers are like clues or signs in our body that can help doctors understand our health. PF-07293893 is being studied as a possible treatment for people with heart disease who have reduced ability to exercise. This study aims to see how the study medicine affects muscle biomarkers related to the ability to exercise.
This study is seeking participants who:
- Are males 18 to 65 years of age and females who are not able to become pregnant;
- Have body mass index of 16 to 32 kilograms per meter square and a total body weight of more than 50 kilograms (110 pounds);
- Over prior 4 weeks have an average of less than:
-150 minutes of moderate-intensity aerobic physical activity throughout each week. Moderate-intensity physical activity feels somewhat hard. Your breathing becomes faster, but you are not out of breath. You can hold a conversation, but you cannot sing.
AND
-75 minutes of vigorous-intensity aerobic physical activity throughout each week. Vigorous-intensity physical activity feels challenging. You are breathing fast and deep. You cannot say more than a few words without pausing.
OR
-An equivalent combination of moderate-and vigorous-intensity activity.
Participants will stay at the study clinic for about four days. On the third day, participants will take the study medicine or placebo (dummy pill) by mouth once at the study clinic and then stay at the study clinic for another day. During this time, the study team will check the treatment and take some blood and muscle tissue samples from the leg. This will help to understand if the study medicine affects muscle biomarkers. Participants will return to the study clinic for a follow-up visit or receive a follow-up telephone call about a month later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males 18 to 65 years of age and females of non-childbearing potential;
- •Body mass index (BMI) of 16 to 32 kg/m2; and a total body weight >50 kg (110 lb);
- •Over prior 4 weeks an average of less than 150 minutes of moderate-intensity aerobic physical activity throughout each week, and less than 75 minutes of vigorous-intensity aerobic physical activity throughout each week, or an equivalent combination of moderate- and vigorous-intensity activity.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease;
- •History of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C;
- •Kidney impairment as defined by an estimated glomerular filtration rate (eGFR) <75 mL/min/1.73 m²;
- •A positive urine drug test;
- •Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
研究组 & 干预措施
Cohort 1
Healthy adult participants will receive a single dose of PF-07293893 or placebo
干预措施: PF-07293893 (Drug)
Cohort 1
Healthy adult participants will receive a single dose of PF-07293893 or placebo
干预措施: Placebo (Drug)
Optional Cohort 2
Healthy adult participants will receive a single dose of PF-07293893 or placebo
干预措施: PF-07293893 (Drug)
Optional Cohort 2
Healthy adult participants will receive a single dose of PF-07293893 or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline of skeletal muscle pACC/tACC ratio
时间窗: Day 1 Pre-dose and 2 & 4 hours Post-dose
次要结局
- Number of Participants with Treatment Related Adverse Events (AEs)(Baseline through Day 36)
- Number of Participants with change from Baseline in Laboratory Test Results(Baseline through Day 36)
- Number of Participants with Clinically Significant Change From Baseline in Vital Signs(Baseline through Day 36)
- Number of Participants with Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECGs)(Baseline and Day 1 Pre-dose and 6 hours Post-dose)
- Number of Participants With Change From Baseline in Physical Examinations(Baseline through Day 36)
- Maximum Observed Plasma Concentration (Cmax)(Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2)
- Area under the serum concentration vs. time curve for 0-24 hours (AUC24)(Day 1 Pre-dose, 0.5, 1, 2, 4, 6, 8 & 12 hours Post-dose and Day 2)