NCT03877562已完成1 期
A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of CORT118335 on Olanzapine-Induced Weight Gain in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Mean Change from Baseline in Body Weight
研究概览
简要总结
This study will investigate if there is any difference in the amount of weight gained by participants taking olanzapine with CORT118335 compared with olanzapine with placebo (a dummy test medicine which looks like CORT118335 but contains no active medicine). Safety and tolerability of CORT118335 when taken with olanzapine will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index 18.0 to 25.0 kg/m^2, inclusive
- •Stable body weight as indicated by assessment at screening and pre-dose
- •Able to swallow the size and number of tablets required
- •Provide written informed consent and agree to adhere to study restrictions and contraception requirements.
排除标准
- •Have received any investigational medicine in a clinical research study within the previous 3 months, or CORT118335 at any time
- •Employee, or immediate family member of a study site or Sponsor employee
- •Have a pregnant partner
- •History of abuse of any drug or alcohol, or regularly consume more than 21 units alcohol/week
- •Smokers or users of e-cigarettes and nicotine replacement products within the last 6 months
- •Clinically significant abnormal results of clinical laboratory safety tests, electrocardiogram, or measurement of heart rate and blood pressure
- •History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, or gastrointestinal disease, neurological or psychiatric disorder
- •History of jaundice or gallstones or had a cholecystectomy
- •Family history or known risk for narrow angle glaucoma
- •Consumed liquorice or other glycyrrhetic acid derivatives regularly in the past 6 months
- •Any condition that could be aggravated by glucocorticoid and/or mineralocorticoid antagonism (e.g., asthma, any chronic inflammatory condition, postural hypotension/orthostatic symptoms)
- •Presence or history of clinically significant allergy
- •Donation or loss of greater than 400 mL of blood within the previous 3 months
- •Are taking, or have taken, any prescribed or over-the-counter drug within 14 days other than paracetamol or standard dose multivitamins. Longer restrictions apply for some medicines.
- •Lactose intolerance.
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Olanzapine plus CORT118335
Experimental
Participants will receive olanzapine 10 mg oral tablets and double-blind CORT118335 600 mg after breakfast once daily for 14 days.
干预措施: Olanzapine (Drug)
Olanzapine plus CORT118335
Experimental
Participants will receive olanzapine 10 mg oral tablets and double-blind CORT118335 600 mg after breakfast once daily for 14 days.
干预措施: CORT118335 (Drug)
Olanzapine plus Placebo
Placebo Comparator
Participants will receive olanzapine 10 mg oral tablets and double-blind placebo matching CORT118335 oral tablets after breakfast once daily for 14 days.
干预措施: Olanzapine (Drug)
Olanzapine plus Placebo
Placebo Comparator
Participants will receive olanzapine 10 mg oral tablets and double-blind placebo matching CORT118335 oral tablets after breakfast once daily for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change from Baseline in Body Weight
时间窗: Pre-dose on Day 1 (Baseline) and Day 15
次要结局
- Mean Change from Baseline in Glucose(Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28)
- Percentage of Participants with One or More Adverse Events(Up to Day 28)
- Mean Change from Baseline in Triglycerides(Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28)
- Percentage of Participants with One or More Serious Adverse Events(Up to Day 28)
- Percentage of Participants Discontinued from the Study due to an Adverse Event(Up to Day 28)
- Mean Change from Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28)
- Plasma PK of CORT118335: Maximum Observed Concentration (Cmax)(Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7)
- Mean Change from Baseline in Insulin(Pre-dose on Day 1 (Baseline), pre-dose on Days 8, 15, and 28)
- Mean Change from Baseline in Waist-to-Hip Ratio(Pre-dose on Day 1 (Baseline), Days 8, 15, and 28)
- Plasma Pharmacokinetics (PK) of CORT118335: Time from Dosing at which Maximum Concentration is Apparent (tmax)(Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7)
- Plasma PK of CORT118335: Area Under the Concentration-Time Curve Over the Dose Interval (AUCtau)(Pre-dose and at pre-specified time points up to 24 hours after dosing on Day 7)
研究者
研究点 (1)
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