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This is an open label, randomized, balanced, single center, single dose, trial to assess the pharmacokinetic (PK) profile of OCA, glyco-OCA and tauro-OCA on an empty stomach (fasted condition) and following a high fat, high calorie meal (fed condition) in a 2-period, 2-sequence, crossover manner.
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Inclusion criteria
Subjects are required to meet the following criteria in order to be included in the trial.
Male or female subjects from 18 to 55 years
Contraception: Female subjects must be postmenopausal, surgically sterile, or if premenopausal, be prepared to use more than 1 effective (≤ 1% failure rate) method of contraception during the trial and until at least 30 days after the last dose of OCA. Effective methods of contraception are considered to be:
Good general health as determined by medical history, and by results of physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests obtained within 14 days prior to Day 0
Body mass index (BMI) of 18 to 28; BMI is determined by the following equation: BMI = weight/height2 (kg/m2).
Willing to abstain from alcohol, caffeine, and xanthine-containing food and beverages for 72 hours prior to each period check in and during participation of the inpatient periods of the trial
Willing and able to give written informed consent
Exclusion criteria
Subjects meeting the following criteria will be excluded from the trial.
Primary purpose
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32 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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