Effect of Food on Pharmacokinetics of Obeticholic Acid (OCA)

NCT01914562 | Completed Phase 1 DMC

• 1 other identifier: 747-104
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Maximum concentration (Cmax) - fed and fasted

  maximum concentration (observed)

  Day 1 and Day 14: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and 14 hours

• Time to maximum concentration (Tmax)

  Time to maximum concentration

  24 hours

• Area under the concentration versus time (AUCt)

  Area under the concentration versus time curve from time 0 to the last sampling time with measurable analyte concentration.

  216 hours

• Area under the concentration versus time curve from 0 to 24 hours (AUC 0-24)

  Area under the concentration versus time curve from 0 to 24 hours with measurable analyte concentration

  24 hours

Study Arms (4)

OCA 10 mg while fasted

EXPERIMENTAL

OCA 10 mg orally in the fasting state

Drug: OCA 10 mg

OCA 10 mg while Fed

EXPERIMENTAL

OCA 10 mg orally in the fed state

Drug: OCA 10 mg

OCA 25 mg while fasted

EXPERIMENTAL

OCA 25 mg orally in the fasting state

Drug: OCA 25 mg

OCA 25 mg while Fed

EXPERIMENTAL

OCA 25 mg orally in the fed state

Drug: OCA 25 mg

Interventions

OCA 10 mg DRUG

OCA 10 mg tablet oral

Also known as: 6α-ethyl chenodeoxycholic acid;(6-ECDCA), INT-747

OCA 10 mg while Fed; OCA 10 mg while fasted

OCA 25 mg DRUG

OCA 25 mg tablet oral

Also known as: 6α-ethyl chenodeoxycholic acid;(6-ECDCA), INT-747

OCA 25 mg while Fed; OCA 25 mg while fasted

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Double barrier method, ie, (a) condom (male or female) with spermicide or (b) diaphragm with spermicide
• Intrauterine device (IUD)
• Vasectomy
• 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

You may not qualify if:

• Subjects meeting the following criteria will be excluded from the trial.
• Prior participation in a clinical trial of OCA (INT-747; 6-ECDCA)
• 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
• 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 within 14 days prior to Day 0 or ingestion of an over the counter medication within 7 days prior to Day 0
• 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)
• History or presence of substance abuse within the past 2 years or positive drug screen tests
• Smoker or user of tobacco or nicotine 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

Sponsors & Collaborators

• Intercept Pharmaceuticals: lead

Study Sites (1)

Celerion, Inc.

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

obeticholic acid

Study Officials

• David Shapiro, MD

  Intercept Pharmaceticals, Inc.

  STUDY DIRECTOR

• Terry E. O'Reilly, MD

  Celrion, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2013
• First Posted: August 2, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 8, 2014

Record last verified: 2014-08

Locations

US (1)