Phase 1b Study of Pharmacokinetic Interaction, Evaluating the Effect of a Single IV Infusion of GGF2 or Placebo on Midazolam Pharmacokinetics in Patients With Heart Failure
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 8
- 主要终点
- Safety and tolerability of GGF2 IV infusion in patients with heart failure assessed by review of Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
The study will examine midazolam pharmacokinetics following single dose administration of 3 planned dose levels of GGF2 .
详细描述
This drug-drug interaction (DDI) study evaluates the potential effect of intravenously administered GGF2 on the elimination kinetics of midazolam.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If female, must be at least 2 years post-menopausal or have bilateral oophorectomy, hysterectomy or documented sterility
- •If male, must have documented sterility (by verbal report or previous vasectomy), or if non-sterile, must agree to use barrier contraception for the entire duration of the trial and until 3 months after the last dose of investigational product. Must also agree not to donate sperm during the study and up to 3 months after the last dose of investigational product
- •Stable coronary disease without unstable angina or acute coronary syndrome in the last 6 months
- •All cardiac medications, specifically beta-blockers, renin-angiotensin system inhibitors, aldosterone antagonists, hydralazine and nitrates are at a stable dose (at least 4 weeks) prior to Day 1
排除标准
- •Any previous exposure to GGF2 or other neuregulins
- •Initiation or change of a prescription medication within the 2 weeks prior to Day 1, and/or concomitant medication regimen is expected to change during the course of the study
- •Known allergic reaction to midazolam, or any of the components of midazolam syrup (including cherry flavoring), or components of GGF2 diluent
- •Known specific hepatic disease; total bilirubin >2 mg/dL, AST > 100 IU
- •History of hepatic impairment (hepatitis B and C)
- •Type I Diabetes
- •Documented stroke or transient ischemic attack (TIA) within 2 months of study enrollment
研究组 & 干预措施
GGF2
Patients will be randomized to receive GGF2 or Placebo and on study day 3 administered a single IV infusion.
Each patient will receive 5 oral doses of Midazolam syrup on study day 1 and days 4 through 7 respectively.
干预措施: GGF2 (Drug)
GGF2
Patients will be randomized to receive GGF2 or Placebo and on study day 3 administered a single IV infusion.
Each patient will receive 5 oral doses of Midazolam syrup on study day 1 and days 4 through 7 respectively.
干预措施: Midazolam (Drug)
Placebo
Patients will be randomized to receive GGF2 or Placebo and on study day 3 administered a single IV infusion.
Each patient will receive 5 oral doses of Midazolam syrup on study day 1 and days 4 through 7 respectively.
干预措施: Placebo (Other)
Placebo
Patients will be randomized to receive GGF2 or Placebo and on study day 3 administered a single IV infusion.
Each patient will receive 5 oral doses of Midazolam syrup on study day 1 and days 4 through 7 respectively.
干预措施: Midazolam (Drug)
结局指标
主要结局
Safety and tolerability of GGF2 IV infusion in patients with heart failure assessed by review of Treatment Emergent Adverse Events (TEAE)
时间窗: 90 days (± 3 days)
Pharmacokinetic (PK) parameter Area Under the Curve (AUC) of a single dose of midazolam when administered prior to and following a single IV infusion of GGF2 or Placebo
时间窗: Day 1 to Day 7
次要结局
- Change from baseline of 2D-Echocardiogram (2D-ECHO) or ECHO with contrast(Visit 1 (day-14 to day-1) and visits 2-5 (day 8 through day 90 ± 3 days))
- Change from baseline of the Six-Minute Walk Test (6MWT)(Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days))
- Change from baseline of metabolic testing measuring maximum capacity of body to transport and use oxygen during incremental exercise (VCO2 and VO2 max)(Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days))
- Change from baseline of the M.D. Anderson Symptom Inventory (MDASI) score(Visit 1 (day-14 to day-1) and visits 3-5 (day 14 through day 90 ± 3 days))