A Phase 1, Single-dose, Open-label, Randomized Crossover and Multiple-dose, Open-label Study to Evaluate the Pharmacokinetics and Safety of Azelaprag in Older Adult Healthy Volunteers

BioAge Labs, Inc.1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2023年11月17日最近更新: 2024年2月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: BioAge Labs, Inc.
入组人数: 16
试验地点: 1
主要终点: Oral bioavailability of azelaprag after oral administration - Total body clearance

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a single-dose, open-label, randomized crossover and multiple-dose, open-label study to evaluate the PK of azelaprag in older adult healthy volunteers.

详细描述

This study is a single-dose, open-label, randomized crossover and multiple-dose, open-label study to evaluate the PK of azelaprag in older adult healthy volunteers. The study will enroll approximately 16 participants.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 60 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Patients who meet ALL the following inclusion criteria will be eligible to participate in the study:
•Healthy male or female volunteers ≥ 60 years of age
•No history or evidence of clinically relevant medical disorders
•Body mass index (BMI) between 18 and 40 kg/m2
•Acceptable physical examination findings, including vital signs, and electrocardiogram (ECG)
•Acceptable clinical laboratory values
•Female participants of non-childbearing potential

排除标准

•Currently receiving treatment with another investigational drug or investigational device within 30 days (or 5 half-lives, whichever is longer)
•Current or previous malignancy within 5 years, with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ, or adenocarcinoma of the prostate
•Positive test result for COVID (rapid test), human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C (HCV) antibodies
•Use of any medications that might affect the metabolism of the study drug as assessed by the Investigator and Sponsor and use of any herbal supplements, vitamins, or nutritional supplements within the 14 days prior to the dose day of each dosing period or during study participation.
•Planned elective surgery within 30 days prior to Screening, during the study period or before the participant's red blood cell (RBC) have returned to normal levels
•Systolic blood pressure > 150 mm Hg or < 90 mm Hg or diastolic blood pressure > 95 mm Hg or < 60 mm Hg
•Unwilling or unable to abstain from the use of nicotine or tobacco containing products (including but not limited to snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) or the use of cannabis or marijuana
•Positive urine drug screen or alcohol breath test at screening and/or known history of drug or alcohol abuse within 1 year prior to screening
•History or evidence of any other clinically significant disorder, condition, or disease, that, in the opinion of the investigator or Sponsor medical monitor, if consulted, would pose a risk to participant safety, or interfere with the study evaluation, procedures, or completion
•Concurrent or previous use of aspirin within 14 days and NSAIDs within 3 days before the dose day of each dosing period.

研究组 & 干预措施

Single dose, 2-way crossover in Part 1, then daily dosing for 14 days in Part 2

Experimental

Study Part 1:

Participants will receive a single Dose A or B on Day 1 and then followed by a crossover to a single Dose B or A on Day 8.

Study Part 2:

Participants in Study Part 2 will receive either a single Dose C or equivalent of Dose C administered twice daily, starting on Day 1 and through Day 14

干预措施: Azelaprag (Drug)