Single Dose and Multiple Dose Trial to Assess Pharmacokinetics of Obeticholic Acid (OCA)

Completed · Phase 1

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT01933503

Run by

Intercept Pharmaceuticals

People needed

24

Starts

2013-10-01

Expected to finish

2013-11-01

Last updated by the study team

2013-12-05

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Subjects meeting any of the following criteria will be excluded from the trial:
• Prior exposure to OCA (INT-747; 6-ECDCA)
• History of known or suspected clinically significant hypersensitivity to OCA or any of its components
• History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the large intestine, eg, inflammatory bowel disease (IBD)
• History of gastrointestinal surgeries or gall bladder removal (cholecystectomy)
• History or presence of a clinically significant cardiovascular, hepatic, diabetic, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, psychiatric, or neoplastic disorder(s)
• History of known or suspected clinically significant hypersensitivity to any drug, aside from penicillin
• Ingestion of a prescription medication, including oral contraceptives and bile acid sequestrants, within 14 days prior to IP dosing or ingestion of an over the counter medication within 7 days prior to IP dosing
• Participation in radiologic examinations involving parenteral administration of iodinated contrast materials within 2 weeks prior to screening, or subsequently through the end of trial participation
• History or presence of alcohol abuse (defined as consumption of more than 210 mL of alcohol per week, or the equivalent of fourteen 4 ounces [oz] glasses of wine or fourteen 12 oz. cans/bottles of beer or wine coolers per week) or positive alcohol tests
• History or presence of substance abuse within the past 2 years or positive drug screen tests
• Smoker or use of any tobacco or nicotine containing products
• Any screening laboratory test for which the results are not within the normal reference range and considered clinically significant
• Participation in another investigational drug trial within 30 days prior to Day 0
• History of noncompliance to medical regimens, or subjects who are considered to be potentially unreliable
• Blood or plasma donation within 30 days prior to Day 0
• Mental instability or incompetence
• Presence of human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) at screening
• Known or suspected Pregnancy

Where it is running

• Spaulding Clinical Research — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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