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This is a single center, open label, randomized, parallel design, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety and tolerability of obeticholic acid (OCA).
Full description
Twenty-four eligible subjects will be enrolled and randomized to 1 of 3 treatment groups (5 mg, 10 mg, or 25 mg) in a treatment ratio of 1:1:1 and no less than a ratio of 1:1 for female: male subjects. The study comprises single dose and multiple dose phases. The randomized dose administered in the single dose phase will be the subject's dose level for the multiple dose phase. A single dose of OCA (5 mg, 10 mg, or 25 mg) will be administered on Day 1. PK, safety, and tolerability will then be assessed for 3 days. On Day 4, the multiple dose phase will begin at the same dose level (5 mg, 10 mg, or 25 mg), with subjects receiving OCA once daily for 14 days. PK, safety, and tolerability will be assessed for 2 weeks at the clinical site following the last investigational product (IP) dose on Day 17. Subjects will be confined at the inpatient trial site from Day 0 until the morning of Day 30. They will return to the study site on Day 37 for follow up.
Enrollment
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Inclusion and exclusion criteria
Subjects are required to meet the following criteria in order to be included in the trial.
Males or females age 18 to 55 years
Contraception: Oral contraceptives are not allowed to be used for 2 weeks prior to trial start, during the trial, and for 30 days after the last dose of OCA. Therefore, 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 for males and females are considered to be the following:
Good general health as determined by medical history and by results of physical exam, vital signs, ECG, and clinical laboratory tests obtained within 14 days prior to IP administration
Body mass index (BMI) between 18 and 30 kg/m2; 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 check in and during participation of the inpatient period of the trial
Willing and able to give written informed consent
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the trial:
Primary purpose
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24 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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