An Open-Label, Randomized, 3-Treatment, 3-Period, 6-Sequence, Balanced Crossover Study to Characterize the Relative Bioavailability of Miricorilant Administered as 50-mg and 100-mg Kinetisol Tablets vs the 50-mg Spray Dried Dispersion Tablet Formulation With an Optional Food Effect Assessment in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Time of Maximum Observed Concentration (Tmax) of Miricorilant
研究概览
简要总结
This single-center, randomized, open-label study will assess the relative bioavailability of 2 miricorilant (CORT118335) tablet formulations.
详细描述
This study will evaluate relative bioavailability of Kinetisol and spray dried dispersion (SDD) miricorilant (CORT118335) tablets. This study will consist of 6 possible treatment sequences across 3 periods for healthy, fed participants. A fourth period may be added to assess the impact of fasted conditions.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to understand written informed consent
- •Willing and able to comply with study requirements
- •Willing to comply with protocol-specified contraception requirements
- •Healthy male or non-pregnant, non-lactating female of non-childbearing potential per Investigator assessment.
- •Body mass index (BMI) of 18.0 to 30.0 kg/m^2 at screening
- •Weight of at least 50 kg at screening
排除标准
- •Serious adverse reaction or hypersensitivity to any drug or formulation excipients
- •History of clinically significant allergy requiring treatment
- •History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder
- •Any form of cancer within the 5 years before the first does of this study
- •History and/or symptoms of adrenal insufficiency
- •History of clinically significant GI disease
- •Condition or history of a condition that could be aggravated by glucocorticoid antagonism or glucocorticoid activation
- •History of additional risk factors for torsades de pointes
- •Poor venous access that limits phlebotomy
- •Clinically significant abnormal clinical chemistry, hematology or urinalysis
- •History or evidence of hypokalemia
- •Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results
- •Evidence of renal impairment at screening
- •Positive serum or highly sensitive urine pregnancy test at screening or first admission
- •Clinically significant ECG abnormalities or vital sign abnormalities at screening or baseline
- •Received any investigational medicinal products (IMP) in a clinical research study within 5 half-lives or within 30 days prior to first dose
- •Donation of blood within 2 months or donation of plasma within 1 week prior to first dose of study medication
- •Are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies in the 14 days before first IMP administration
- •Currently using glucocorticoids or have a history of systemic glucocorticoid use at any dose within the last 12 months before first IMP administration or 3 months for inhaled products
- •History of any drug or alcohol abuse in the past 2 years
- •Regular alcohol consumption as defined in the study protocol
- •A confirmed positive alcohol urine test at screening or first admission
- •Current smokers and those who have smoked within the last 12 months
- •Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
- •A confirmed positive urine cotinine test at screening or first admission
- •Positive drug screen test result at screening or first admission
- •Male subjects with pregnant or lactating partners
- •Study site or Sponsor employee or immediate family members one
- •Failure to satisfy the Investigator of fitness to participate for any other reason.
研究组 & 干预措施
Miricorilant Treatment Sequence A, B, C
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment B; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment A (Drug)
Miricorilant Treatment Sequence A, B, C
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment B; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment B (Drug)
Miricorilant Treatment Sequence A, B, C
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment B; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment C (Drug)
Miricorilant Treatment Sequence B, C, A
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B, in Period 2, treatment C; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment A (Drug)
Miricorilant Treatment Sequence B, C, A
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B, in Period 2, treatment C; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment B (Drug)
Miricorilant Treatment Sequence B, C, A
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B, in Period 2, treatment C; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment C (Drug)
Miricorilant Treatment Sequence C, A, B
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment A; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment A (Drug)
Miricorilant Treatment Sequence C, A, B
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment A; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment B (Drug)
Miricorilant Treatment Sequence B, A, C
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B; in Period 2, treatment A; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment A (Drug)
Miricorilant Treatment Sequence B, A, C
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B; in Period 2, treatment A; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment B (Drug)
Miricorilant Treatment Sequence B, A, C
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment B; in Period 2, treatment A; in Period 3, treatment C. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment C (Drug)
Miricorilant Treatment Sequence C, A, B
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment A; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment C (Drug)
Miricorilant Treatment Sequence A, C, B
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment C; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment A (Drug)
Miricorilant Treatment Sequence A, C, B
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment C; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment B (Drug)
Miricorilant Treatment Sequence A, C, B
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment A; in Period 2, treatment C; in Period 3, treatment B. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment C (Drug)
Miricorilant Treatment Sequence C, B, A
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment B; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment A (Drug)
Miricorilant Treatment Sequence C, B, A
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment B; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment B (Drug)
Miricorilant Treatment Sequence C, B, A
Participants will receive a single dose of study drug in a fed state on Day 1 of each of 3 treatment periods. In Period 1, treatment C; in Period 2, treatment B; in Period 3, treatment A. A washout period of at least 7 days will follow each dose of the study drug.
干预措施: Miricorilant Treatment C (Drug)
Optional Miricorilant Treatment D
After completion of Period 3, analysis of pharmacokinetic and safety data will be used to decide if Period 4 will be conducted. In Period 4, selected participants will receive a single dose of treatment D in a fasted state on Day 1.
干预措施: Miricorilant Treatment D (Drug)
结局指标
主要结局
Time of Maximum Observed Concentration (Tmax) of Miricorilant
时间窗: Predose and at serial timepoints up to 72 hours postdose
Maximum Observed Concentration (Cmax) of Miricorilant
时间窗: Predose and at serial timepoints up to 72 hours postdose
Concentration at 24 Hours Postdose (C24) of Miricorilant
时间窗: Predose and at serial timepoints up to 24 hours postdose
Area Under the Curve from Time 0 to the Time of Last Measurable Concentration (AUC[0-last]) of Miricorilant
时间窗: Predose and at serial timepoints up to 72 hours postdose
Area Under the Curve from Time 0 Extrapolated to Infinity (AUC[0-inf]) of Miricorilant
时间窗: Predose and at serial timepoints up to 72 hours postdose
Terminal Elimination Half-Life (T1/2) of Miricorilant
时间窗: Predose and at serial timepoints up to 72 hours postdose
Relative Bioavailability (Frel) for Miricorilant Based on Cmax
时间窗: Predose and at serial timepoints up to 72 hours postdose
Frel for Miricorilant based on AUC(0-last)
时间窗: Predose and at serial timepoints up to 72 hours postdose
Frel for Miricorilant Based on AUC(0-inf)
时间窗: Predose and at serial timepoints up to 72 hours postdose
次要结局
- Number of Participants with Abnormal, Clinically Significant Clinical Laboratory Findings(Day -1 and 72 hours postdose in periods 3 and 4)
- Number of Participants with Abnormal, Clinically Significant 12-Lead Electrocardiogram (ECG) Findings(Day -1, predose, and at 4 and 72 hours postdose in every study period)
- Number of Participants with Abnormal, Clinically Significant Vital Sign Findings(Day -1, predose, and at serial time points up to 72 hours postdose in every study period)
- Number of Participants with Abnormal, Clinically Significant Physical Exam Findings(72 hours postdose in periods 3 and 4)
- Number of Participants with 1 or More Adverse Events(Screening up to 30 days postdose)