A Phase 1, Open-label, Randomized, Five-Part Study to Assess the Pharmacokinetics and Safety of Tablet and Capsule Formulations of HU6 in Overweight Participants.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- b. To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on the exposure parameter of maximum concentration (Cmax).
研究概览
简要总结
This is a five-part study being conducted to evaluate the safety, tolerability and pharmacokinetics of the HU6 tablet and capsule formulations at steady state in the fed and fasted state for HU6 450 mg once daily (QD) dose (as single or multiple tablets) or HU6 300 mg twice daily (BID) (supplied as two 150 mg tablets) or HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD or HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD.
详细描述
This is a five-part study being conducted to evaluate the safety, tolerability and pharmacokinetics of the HU6 tablet and capsule formulations at steady state in the fed and fasted state for 450 mg once daily (QD) dose (as single or multiple tablets) or 300 mg twice daily (BID) (supplied as two 150 mg tablets) or HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD or HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD. Population pharmacokinetic (popPK) modeling indicated a potential difference in PK profile when multiple dose units are administered versus a single dose unit in tablet and capsule formulations.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between 18 and 55 years of age at time of signing the informed consent.
- •Body mass index (BMI) ≥ 25 kg/m2 at Screening.
- •Medically stable in the opinion of the investigator based on medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and general observations. Note that Screening abnormalities or findings outside the normal ranges for any clinical assessments that are considered clinically significant by the Investigator (clinical laboratory tests, ECG, vital signs) may be repeated once at the discretion of the Investigator(s), and results that continue to be outside the normal ranges must be judged by the investigator to be not clinically significant and acceptable for study participation.
- •Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this clinical protocol.
排除标准
- •Current or past clinically significant history of cardiovascular, cerebrovascular, pulmonary, gastrointestinal, hematologic, renal, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, or other major disease as determined by the investigator and if deemed necessary, in consultation with the medical monitor, which may impact safety.
- •History of cancer (except for treated non-melanoma skin cancer) or history of chemotherapy use within 5 years prior to Screening.
- •Any surgical or medical condition or history that, in the opinion of the investigator, and if deemed necessary, in consultation with the medical monitor, may potentially alter the absorption, metabolism, or excretion of IMP, such as, but not limited to, gastric bypass surgery or gallbladder removal surgery or significant small bowel resections.
- •Contraindication to IMP or its excipients and/or history of anaphylactic reactions or clinically significant allergic reaction.
研究组 & 干预措施
Experimental: Active Treatment HU6 450 mg tablet
Drug: HU6 450 mg single tablet once daily (QD)
干预措施: HU6 (Drug)
Experimental: Active Treatment HU6 150 mg x 3 tablets
Drug: HU6 150 mg x 3 tablets QD
干预措施: HU6 (Drug)
Experimental: Active Treatment HU6 (150 mg tablet × 2) BID
Drug: HU6 300 mg dose (supplied as HU6 150 mg tablet × 2) BID (q12 hours)
干预措施: HU6 (Drug)
Experimental: Active Treatment HU6 150 mg drug substance in a capsule × 3 (450 mg total)
Drug: HU6 150 mg drug substance in a capsule × 3 (450 mg total dose) QD
干预措施: HU6 (Drug)
Experimental: Active Treatment HU6 150 mg granulated blend in a capsule × 3 (450 mg total)
Drug: HU6 150 mg granulated blend in a capsule × 3 (450 mg total dose) QD
干预措施: HU6 (Drug)
结局指标
主要结局
b. To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on the exposure parameter of maximum concentration (Cmax).
时间窗: 28 days
To estimate multiple dose plasma pharmacokinetics of HU6 with emphasis on exposure parameters of maximum concentration (Cmax), after multiple dose administration of the tablet and capsule formulations of HU6
次要结局
未报告次要终点