liver diseases
Conditions
Interventions
Part A:
Group 1 Day 1 once INT-787 2.5 mg or placebo
Group 1 Day 1 once INT-787 5 mg or placebo
Group 3 Day 1 once INT-787 10 mg or placebo
Group 4 Day 1 once INT-787 25 mg or placebo
Group 5 Day 1 on
Sponsors
Intercept Pharmaceuticals, Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject must be male (18 to 55 years of age, inclusive) or female (gender effect cohort only; 18 to 55 years of age, inclusive). 2. Female subjects (included in the gender effect cohort only) must be of non-childbearing potential, who have undergone a sterilization procedure at least 6 months prior to dosing with official documentation (e.g., hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy, hysterectomy, or bilateral oophorectomy), or are postmenopausal with amenorrhea for at least 1 year prior to dosing and folliclestimulating hormone (FSH) serum levels consistent with postmenopausal status and serum pregnancy test at screening and upon admission with a negative result as per Investigator*s judgment. 3.Male subjects who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control (e.g., either condom or partner with occlusive cap [diaphragm or cervical/vault caps]). Male subjects must also agree to not donate sperm for the duration of the study and for at least 90 days after study discharge. 4. Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening. 5. Judged to be in good health on the basis of medical history, physical examination, and routine laboratory measurements (i.e., without clinically relevant pathology).
Exclusion criteria
Exclusion criteria: 1.History of any illness or condition that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering investigational product to the subjects. 2. Smokers (subjects who have smoked within 3 months of screening or those with positive results from the cotinine urine test). 3. Inflammatory bowel disease, cholecystectomy or surgery of the gastrointestinal tract that could interfere with pharmacokinetics of the study medication (except appendectomy and simple hernia repair). 4. Routine treatment with prescription medications. Subjects should have stopped taking any prescription and nonprescription medications at least 14 days before the first dosing of investigational product. Potential subjects should only stop taking any prescription and nonprescription medications at the direction of a physician. 5. Consumption of herbal medications, dietary supplements, and specific fruit products. Subjects should have stopped consumption of herbal medications or dietary supplements (e.g., St. John*s Wort, ginkgo biloba, and garlic supplements), vitamins, grapefruit, grapefruit hybrids or grapefruit juice, Seville oranges, pomelos, cranberries, pomegranates, star fruit, apples, vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, Brussels sprouts, and mustard) and charbroiled meats for 7 days prior to Day 1, on any dosing day, and through the completion of the last PK sampling.1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: To evaluate the safety and tolerability of single ascending doses of INT-787 capsule(s) administered orally to healthy male and female subjects Part B: To evaluate the safety and tolerability of multiple ascending doses of INT-787 capsule(s) administered orally for 14 days to healthy male subjects Part C: To assess the food effect on the PK of INT-787, and its tauro- and glyco- conjugates (and other metabolites as applicable) following administration of a single dose of INT-787 capsule(s) administered orally to healthy male subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: To evaluate the pharmacokinetics (PK) of INT-787, and its tauro- and glycoconjugates (and other metabolites as applicable) following administration of single ascending doses of INT-787 capsule(s) administered orally to healthy subjects To assess the gender effect on the PK of INT-787, and its tauro-and glyco-conjugates (and other metabolites as applicable) following administration of a single dose of INT-787 capsule(s) administered orally to healthy subjects. To explore the possible relationships between dose, exposure, and FXR activation biomarker responses as well as biomarkers of kidney function after single ascending doses of INT-787. Part B: To evaluate the PK of INT-787, and its tauro- and glyco- conjugates (and other metabolites as applicable) following administration of multiple ascending doses of INT-787 capsule(s) administered orally to healthy male subjects Part C: To evaluate the safety and tolerability of a single dose of INT-787 capsule(s) administered orally to healthy male subjects in fasted and fed conditions | — |
Countries
Netherlands
Outcome results
None listed