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

NCT ID: NCT01933503

Last Updated: 2013-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2013-11-30

Brief Summary

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).

Detailed 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.

Conditions

Healthy

Keywords

MAD; SAD; Obeticholic Acid (OCA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

OCA 5 mg

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

OCA 10 mg

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

OCA 25 mg

Intervention Type: DRUG

Interventions

OCA 5 mg

Intervention Type: DRUG

OCA 10 mg

Intervention Type: DRUG

OCA 25 mg

Intervention Type: DRUG

Other Intervention Names

INT-747; 6α-ethyl chenodeoxycholic acid; 6-ECDCA; INT-747; 6α-ethyl chenodeoxycholic acid; 6-ECDCA; INT-747; 6α-ethyl chenodeoxycholic acid; 6-ECDCA

Eligibility Criteria

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from the trial:

1. Prior exposure to OCA (INT-747; 6-ECDCA)

2. History of known or suspected clinically significant hypersensitivity to OCA or any of its components

3. 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)

4. History of gastrointestinal surgeries or gall bladder removal (cholecystectomy)

5. History or presence of a clinically significant cardiovascular, hepatic, diabetic, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, psychiatric, or neoplastic disorder(s)

6. History of known or suspected clinically significant hypersensitivity to any drug, aside from penicillin

7. 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

8. 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

9. 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

10. History or presence of substance abuse within the past 2 years or positive drug screen tests

11. Smoker or use of any tobacco or nicotine containing products

12. Any screening laboratory test for which the results are not within the normal reference range and considered clinically significant

13. Participation in another investigational drug trial within 30 days prior to Day 0

14. History of noncompliance to medical regimens, or subjects who are considered to be potentially unreliable

15. Blood or plasma donation within 30 days prior to Day 0

16. Mental instability or incompetence

17. Presence of human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) at screening

18. Known or suspected Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Intercept Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Shaprio, M.D.

Role: STUDY_DIRECTOR

Intercept Pharmaceuticals, San Diego, CA 92122

Locations

Spaulding Clinical Research

West Bend, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30144429 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27743502 (View on PubMed)

Other Identifiers

747-105

Identifier Type: -

Identifier Source: org_study_id