A Single-Center, Randomized, Open-Label, 2-Period Complete Crossover Study to Compare the Bioavailability of a Capsule Formulation of LGD-6972 to an Oral Solution Formulation in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetics Analysis- Area Under the Concentration Curve (AUC)
研究概览
简要总结
The purpose of this study is to compare relative oral bioavailability of a capsule formulation of LGD-6972 to a solution formulation of LGD-6972.
详细描述
This is a single center, randomized, open-label, single dose study conducted in a 2-way crossover design.
A total of 8 subjects will be enrolled in the study. The duration of participation for each subject will be approximately 36 days, not including a Screening Period of up to 30 days.
Each treatment period, subjects will be admitted to the study site on Day -1 and observed through the morning of Day 3 (48-hour post-dose assessment). Over 2 treatment periods, subjects will receive each of the following treatments as a single dose orally, under fasting conditions, per the randomization (4 subjects per treatment in each treatment period:
Treatment A - 15 mg of LGD-6972 as capsules
Treatment B - 15 mg LGD-6972 as solution
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
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult man or woman, 21 to 65 years of age. If the subject is a woman, she must be surgically sterile (hysterectomy or bilateral oophorectomy or bilateral tubal ligation), or naturally post menopausal for at least 12 months and with a follicle stimulating hormone (FSH) level in the post-menopausal range (if not taking hormone replacement therapy) to be considered for enrollment
- •Willing and able to provide written informed consent
- •Not diabetic and has a fasting blood glucose between 70 and 105 mg/dL, inclusive
- •In good health with no significant concomitant pathology based on medical history, physical examination, ECG, routine laboratory tests (chemistry, hematology, lipid profile, and urinalysis), and vital signs
- •Has a body mass index (BMI) between 18.5 kg/m2 and 30 kg/m2, inclusive, and must weigh more than 45 kg
- •Male subjects must either have a vasectomy or agree that they and any female partners will use 2 acceptable forms of contraception, one of which must be a condom, until 30 days after the last dose of study drug. Other acceptable forms of contraception include hormonal contraceptives, intrauterine device, Depo Provera®, Norplant® System Implants, bilateral tubal ligation, bilateral oophorectomy, hysterectomy, and contraceptive sponge, foam, or jelly.
排除标准
- •History of drug and/or alcohol abuse within 2 years prior to screening
- •Unwilling to comply with tobacco, nicotine, alcohol, and caffeine restrictions outlined in the protocol
- •Unwilling to comply with restrictions on strenuous exercise as specified in the protocol
- •Has a history of clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, neurologic, psychiatric, immunologic, hematologic, gastrointestinal (including pancreatitis), or metabolic disease requiring medical treatment or has any medical problems that pose an increased risk during the study or that may compromise the integrity of the study data
- •Has liver transaminase levels (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) 10% of the upper limit of normal (ULN), or has creatine kinase (CK) levels 2 × ULN at screening or admission to site (Day 1). Abnormal values at screening may be retested once
- •Has a serum triglyceride level 400 mg/dL at screening. If the triglyceride level is between 400 mg/dL and 500 mg/dL, one retest is permitted
- •Recent history of uncontrolled high blood pressure or has systolic blood pressure 90 mmHg or 140 mmHg or diastolic blood pressure 50 mmHg or 90 mmHg at screening. One or more retests of blood pressure within a reasonable period of time are permissible at the discretion of the Investigator
- •Is taking prescription or non-prescription drugs other than those outlined in the protocol
- •Has a positive screening for hepatitis B virus (HBV), hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV)
- •Woman of childbearing potential
- •Lactating or has a positive pregnancy test
- •Has donated 450 mL of blood within 56 days of admission to the investigational site or has donated blood products within 30 days of admission.
研究组 & 干预措施
Period 1 Treatment A
Healthy subjects will receive a single dose orally of LGD-6972 capsules fasted
干预措施: LGD-6972 Capsules (Drug)
Period 1 Treatment B
Healthy subjects will receive a single dose orally of LGD-6972 solution fasted
干预措施: LGD-6972 Solution (Drug)
Period 2 Treatment A
Healthy subjects will receive a single dose orally of LGD-6972 capsules fasted
干预措施: LGD-6972 Capsules (Drug)
Period 2 Treatment B
Healthy subjects will receive a single dose orally of LGD-6972 solution fasted
干预措施: LGD-6972 Solution (Drug)
结局指标
主要结局
Pharmacokinetics Analysis- Area Under the Concentration Curve (AUC)
时间窗: Pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hrs, 7 and 14 days post dose
AUC: ratio: medium test form to reference form
Pharmacokinetics Analysis- Maximum Concentration (Cmax)
时间窗: Pre-dose, 1,2,4,6,8,10,12,16,24,36,48,72 hrs, 7 and 14 days post dose
Cmax: ratio: medium test form to reference form
次要结局
- Severity of all Adverse Events graded according to the Common Terminology Criteria for Adverse Events (CTCAE)(Day -1, 24, 48, 72hrs, and 7day and 14day post dose)