- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01933503
Single Dose and Multiple Dose Trial to Assess Pharmacokinetics of Obeticholic Acid (OCA)
An Open Label, Randomized, Single Dose and Multiple Dose Trial to Assess the Pharmacokinetics of Obeticholic Acid (OCA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Wisconsin
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West Bend, Wisconsin, United States, 53095
- Spaulding Clinical Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Double barrier method, ie, (i) condom, with spermicide (male or female) or (ii) diaphragm with spermicide
- Intrauterine device (IUD)
- Vasectomy (partner)
- 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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: OCA 5 mg
OCA 5 mg, 1 mg by mouth followed by 2 days of no investigational product (IP); then OCA 5 mg by mouth for 14 days.
|
Other Names:
|
Experimental: OCA 10 mg
OCA 10 mg, 1 mg by mouth followed by 2 days of no investigational product (IP); then OCA 10 mg by mouth for 14 days.
|
Other Names:
|
Experimental: OCA 25 mg
OCA 25 mg, 1 mg by mouth followed by 2 days of no investigational product (IP); then OCA 25 mg by mouth for 14 days.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum concentration (Cmax observed)
Time Frame: 3 days - single dose, 33 days - Multi dose
|
Maximum concentration (observed) following single and multiple doses of OCA 5 mg, 10 mg, and 25 mg
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3 days - single dose, 33 days - Multi dose
|
Time to maximum concentration (tmax)
Time Frame: 3 days - single dose, 33 days - Multi dose
|
Time to maximum concentration (tmax)
|
3 days - single dose, 33 days - Multi dose
|
Area under the concentration vs. time curve (AUCt)
Time Frame: 3 days - single dose, 33 days - Multi dose
|
Area under the concentration vs. time curve (AUCt) from time 0 to the last sampling time with measurable analyte concentration, calculated by the linear trapezoidal method
|
3 days - single dose, 33 days - Multi dose
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Area under the concentration vs. time curve from time 0 to 24 hours (AUC0-24)
Time Frame: 24 hours
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Area under the concentration vs. time curve from time 0 to 24 hours (AUC0-24) with measurable analyte concentration, calculated by the linear trapezoidal method
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24 hours
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The ratio of each conjugate to OCA
Time Frame: 3 days - single dose, 33 days - Multi dose
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The ratio of each conjugate to OCA for exposure PK parameters for both single and multiple dose assessments.
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3 days - single dose, 33 days - Multi dose
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Accumulation ratios (Rac) based on AUC, Cmax and Cmin
Time Frame: 17 days
|
Accumulation ratios (Rac) based on AUC, Cmax and Cmin will be calculated for OCA and its conjugates (glyco-OCA and tauro-OCA) from Day 1 to Day 17
|
17 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: David Shaprio, M.D., Intercept Pharmaceuticals, San Diego, CA 92122
Publications and helpful links
General Publications
- Edwards JE, LaCerte C, Peyret T, Gosselin NH, Marier JF, Hofmann AF, Shapiro D. Modeling and Experimental Studies of Obeticholic Acid Exposure and the Impact of Cirrhosis Stage. Clin Transl Sci. 2016 Dec;9(6):328-336. doi: 10.1111/cts.12421. Epub 2016 Oct 15.
- Friedman ES, Li Y, Shen TD, Jiang J, Chau L, Adorini L, Babakhani F, Edwards J, Shapiro D, Zhao C, Carr RM, Bittinger K, Li H, Wu GD. FXR-Dependent Modulation of the Human Small Intestinal Microbiome by the Bile Acid Derivative Obeticholic Acid. Gastroenterology. 2018 Dec;155(6):1741-1752.e5. doi: 10.1053/j.gastro.2018.08.022. Epub 2018 Aug 23.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 747-105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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