HealthyPhase 1NCT01914562
Effect of Food on Pharmacokinetics of Obeticholic Acid (OCA)
A Phase 1 study testing OCA 10 mg and OCA 25 mg in people with Healthy, run by Intercept Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- OCA 10 mg and OCA 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Mental instability or incompetence
- Presence of human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Trial to Assess the Effects of Food on the Pharmacokinetic Parameters of Obeticholic Acid (OCA)
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
- Being tested
- OCA 10 mg, OCA 25 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCA 10 mgDrug
Also called 6α-ethyl chenodeoxycholic acid;(6-ECDCA), INT-747
OCA 10 mg tablet oral
OCA 25 mgDrug
Also called 6α-ethyl chenodeoxycholic acid;(6-ECDCA), INT-747
OCA 25 mg tablet oral
| Study group | Role | What they receive |
|---|---|---|
| OCA 10 mg while fasted | Experimental | OCA 10 mg orally in the fasting state Receives: Drug: OCA 10 mg |
| OCA 10 mg while Fed | Experimental | OCA 10 mg orally in the fed state Receives: Drug: OCA 10 mg |
| OCA 25 mg while fasted | Experimental | OCA 25 mg orally in the fasting state Receives: Drug: OCA 25 mg |
| OCA 25 mg while Fed | Experimental | OCA 25 mg orally in the fed state Receives: Drug: OCA 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) - fed and fasted
maximum concentration (observed)
Measured: 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
Measured: 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.
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intercept Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Shapiro, MD, Study director, Intercept Pharmaceticals, Inc.Terry E. O'Reilly, MD, Principal investigator, Celrion, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914562
- Sponsor's protocol ID
- 747-104
- Status last verified
- Aug 2014
- First submitted
- 31 Jul 2013
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Trial to Assess the Effects of Food on the Pharmacokinetic Parameters of Obeticholic Acid (OCA)
- ClinicalTrials.gov ID
- NCT01914562
- Acronym / sponsor ID
- 747-104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Intercept PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OCA 10 mg while fasted | Experimental | Drug: OCA 10 mgOCA 10 mg orally in the fasting state |
| OCA 10 mg while Fed | Experimental | Drug: OCA 10 mgOCA 10 mg orally in the fed state |
| OCA 25 mg while fasted | Experimental | Drug: OCA 25 mgOCA 25 mg orally in the fasting state |
| OCA 25 mg while Fed | Experimental | Drug: OCA 25 mgOCA 25 mg orally in the fed state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- 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).
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCA 10 mgAlso: 6α-ethyl chenodeoxycholic acid;(6-ECDCA), INT-747OCA 10 mg tablet oral | Drug | OCA 10 mg while Fed, OCA 10 mg while fasted |
| OCA 25 mgAlso: 6α-ethyl chenodeoxycholic acid;(6-ECDCA), INT-747OCA 25 mg tablet oral | Drug | OCA 25 mg while Fed, OCA 25 mg while fasted |
Primary outcome
Maximum concentration (Cmax) - fed and fasted
Time frame: 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
maximum concentration (observed)
Time to maximum concentration (Tmax)
Time frame: 24 hours
Time to maximum concentration
Area under the concentration versus time (AUCt)
Time frame: 216 hours
Area under the concentration versus time curve from time 0 to the last sampling time with measurable analyte concentration.
Area under the concentration versus time curve from 0 to 24 hours (AUC 0-24)
Time frame: 24 hours
Area under the concentration versus time curve from 0 to 24 hours with measurable analyte concentration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Shapiro, MD study director
Intercept Pharmaceticals, Inc.
Terry E. O'Reilly, MD principal investigator
Celrion, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OCA 10 mg and OCA 25 mg in people with Healthy, run by Intercept Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum concentration (Cmax) - fed and fasted (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.