The Safety, Tolerability and Pharmacokinetic Study of HEC585 in Healthy Male and Female Subjects
- Registration Number
- NCT03092102
- Lead Sponsor
- Sunshine Lake Pharma Co., Ltd.
- Brief Summary
The Safety, Tolerability and Pharmacokinetic Study of idiopathic pulmonary fibrosis treatment drug HEC585 in Healthy Male and Female Subjects
- Detailed Description
This will be a double-blind, placebo-controlled, single, and multiple oral dose study conducted in 2 parts.
Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Up to 48 subjects will be studied in up to 6 groups (Groups A1 to A6), with each group consisting of 8 subjects. Each subject will participate in 1 treatment period only and reside at the clinical research unit (CRU) from Day -1 (the day before dosing) to Day 7 (144 hours postdose), except for Group A3, which will participate in a second treatment period for a food effect evaluation. Each subject in Group A3 will participate in 2 treatment periods separated by a minimum of 7 days. Dosing of subjects in the fed state in Group A3 can commence after review of the safety data from Group A4.
Part B will comprise a multiple-dose, sequential-group study. Up to 36 subjects will be studied in up to 3 groups (Groups B1 to B3), with each group consisting of 12 subjects. Part B of the study may start after completion of Group A5, at a dose equal or less than given in Groups A1 to A3.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- Males or females, of any race, between 18 and 60 years of age, inclusive, at Screening.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive, at Screening.
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, Gilbert's syndrome] is not acceptable) at Screening and/or Check-in as assessed by the Investigator (or designee).
- Females will be nonpregnant and nonlactating. Females of childbearing potential and male subjects will agree to use contraception.
- Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
- History of alcoholism or drug/chemical abuse within 2 years prior to Check-in.
- Alcohol consumption of > 21 units per week for males and > 14 units for females. One unit of alcohol equals 12 oz (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL wine), or a positive alcohol breath test at Check-in.
- Positive urine drugs of abuse screen including cotinine at Screening or Check-in.
- Positive hepatitis B surface antigen, hepatitis C virus antibody and/or positive human immunodeficiency virus (HIV) test (Appendix 3).
- Absolute lymphocyte count below the lower limit of normal which can be confirmed by repeat.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (if known), whichever is longer, prior to Check-in.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's Wort, within 30 days prior to Check-in, unless deemed acceptable by the Investigator (or designee). Strong CYP3A inhibitors and inducers should be avoided.
- Use or intend to use any prescription medications/products, within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use of tobacco- or nicotine-containing products within 3 months prior to Check-in.
- Consumption of foods and beverages containing poppy seeds, grapefruit, or Seville oranges within 7 days prior to Check-in, consumption of caffeine-containing foods and beverages within 72 hours prior to Check-in, or consumption of alcohol within 48 hours prior to Check-in.
- Receipt of blood products within 2 months prior to Check-in.
- Donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study, and have previously received the investigational product.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A single dose HEC585（A8） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule A single dose HEC585（A1） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule A single dose HEC585（A2） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule A single dose HEC585（A4） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule A single dose HEC585/FE（A3） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule Treatment Period 1：No food prior to dosing；Treatment Period 2：High-fat meal prior to dosing A single dose HEC585（A5） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule A single dose HEC585（A6） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule Multiple doses HEC585（B1） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule A single dose HEC585（A7） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule Multiple doses HEC585（B2） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule Multiple doses HEC585（B3） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule Multiple doses HEC585（B4） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule Multiple doses HEC585（B5） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule Multiple doses HEC585（B6） HEC585 Drug: HEC585 Capsule Drug: HEC585-matching placebo Capsule
- Primary Outcome Measures
Name Time Method Cmax Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h Geometric Mean of Maximum Observed Plasma Concentration of HEC585
(AUC0-∞） Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120,144,and 216 h area under the plasma concentration-time curve (AUC) from time zero to infinity
tmax Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h time of the maximum observed plasma concentration
Vz/F Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120,144,and 216 h apparent volume of distribution
t½ Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h apparent terminal elimination half-life
CL/F Predose, and 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144,and 216 h apparent oral clearance
- Secondary Outcome Measures
Name Time Method Adverse event From baseline to 7 days To assess the safety and tolerability of 7 days therapy.
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc.
🇺🇸Madison, Wisconsin, United States