A PHASE 1, OPEN-LABEL, 2-PART STUDY TO ESTIMATE SEPARATELY THE EFFECT OF ITRACONAZOLE AND FOOD ON THE PHARMACOKINETICS OF PF-07258669 IN OLDER ADULT OR HEALTHY ADULT PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to learn how the medicine called itraconazole and food changes how the body processes another study medicine called PF-07258669 in older adults or healthy adults.
The study medicine PF-07258669 is developed for the treatment of unintended weight loss in older adults. People with this condition have decreased appetite and food intake, which is an important reason for poor nutrition and health results in people with unintended weight loss. The study has two parts: Part A and Part B.
The study is seeking participants who:
- Are males or females who can no longer have children.
- Part A Only: Are at least 65 years old and in reasonably good health. Part B Only: Are at least 18 years old and in good health.
- Part A Only: Have a body mass index (BMI) of 16 to 27 kilogram per meter squared and a total body weight of more than 40 kilograms (88 pounds). Part B Only: Have a BMI of 16-32 kilogram per meter squared and a total body weight of more than 50 kilograms (110 pounds).
For Part A: Participants will take the study medicine PF-07258669 as tablets by mouth once on Day 1 at the study clinic and stay at the clinic for about 12 days. Then starting on Day 4, participants will take itraconazole as liquid by mouth for eight days. On Day 7, itraconazole will be taken together with PF-07258669.
For Part B: Participants will take the study medicine PF-07258669 as tablets by mouth once on Day 1 without breakfast at the study clinic and stay at the clinic for about 7 days. On Day 4, participant will take the study medicine after breakfast. A different group of participants will follow a similar procedure, but they will take the medicine after breakfast on Day 1 and without breakfast on Day 4.
For Parts A and B: At the clinic, the study team will observe the participants and take urine and blood samples to look at the levels of PF-07258669. The participants will receive a follow up telephone call about one month later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Parts A and B are not masked. Part A is not randomized. Part B is randomized to Sequence 1 or Sequence 2.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females who can no longer have children.
- •Part A Only: At least 65 years old. Part B Only: At least 18 years old.
- •In reasonably good health.
- •Part A Only: Body mass index (BMI) of 16-27 kg/m2; and a total body weight >40 kg (88 lb.). Part B Only: BMI of 16-32 kg/m2; and a total body weight >50 kg (110 lb.).
- •Exclusion criteria
- •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.
排除标准
- 未提供
研究组 & 干预措施
Part A: Period 1
A single oral dose of PF-07258669 on Study Day 1
干预措施: PF-07258669 (Drug)
Part A: Period 2
Itraconazole QD orally on Study Days 4 to 11. PF-07258669 will be co administered on Study Day 7.
干预措施: PF-07258669 (Drug)
Part A: Period 2
Itraconazole QD orally on Study Days 4 to 11. PF-07258669 will be co administered on Study Day 7.
干预措施: Itraconazole (Drug)
Part B: Sequence 1
A single oral dose of PF-07258669 on Study Days 1 and 4 under fasted and fed conditions respectively.
干预措施: PF-07258669 (Drug)
Part B: Sequence 2
A single oral dose of PF-07258669 on Study Days 1 and 4 under fed and fasted conditions respectively.
干预措施: PF-07258669 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: Baseline to Day 12 (Part A); Baseline to Day 7 (Part B)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
时间窗: Baseline to Day 12 (Part A); Baseline to Day 7 (Part B)
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) [if data permit, otherwise AUClast]
时间窗: Baseline to Day 12 (Part A); Baseline to Day 7 (Part B)
次要结局
- Number of Participants With Treatment Emergent Adverse Events(Baseline to Day 46 (Part A); Baseline to Day 39 (Part B))