A three-part, phase 1, randomized, controlled, dose-escalation study of INT-787 following single or multiple dose administration in healthy subjects.
- Conditions
- liver diseases10019654
- Registration Number
- NL-OMON52038
- Lead Sponsor
- Intercept Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A:<br /><br>To evaluate the safety and tolerability of single ascending doses of INT-787<br /><br>capsule(s) administered orally to healthy male and female subjects<br /><br><br /><br>Part B:<br /><br>To evaluate the safety and tolerability of multiple ascending doses of INT-787<br /><br>capsule(s) administered orally for 14 days to healthy male subjects<br /><br><br /><br>Part C:<br /><br>To assess the food effect on the PK of INT-787, and its tauro- and glyco-<br /><br>conjugates (and other metabolites as applicable) following administration of a<br /><br>single dose of INT-787 capsule(s) administered orally to healthy male subjects</p><br>
- Secondary Outcome Measures
Name Time Method