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HealthyPhase 1NCT01933503

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

A Phase 1 study testing OCA 5 mg, OCA 10 mg and OCA 25 mg in people with Healthy, run by Intercept Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). 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 5 mg, 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
24 participants
Where
1 siteUnited States
Study dates
Oct 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

None listed.

Who cannot join

  • 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)
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Spaulding Clinical Research

    West Bend, Wisconsin, 53095

Other trials in United States

About this study

Official title: An Open Label, Randomized, Single Dose and Multiple Dose Trial to Assess the Pharmacokinetics of Obeticholic Acid (OCA)

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).

Read the 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
Being tested
OCA 5 mg, OCA 10 mg, OCA 25 mg
Keywords
MAD, SAD, Obeticholic Acid (OCA)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OCA 5 mgDrug

    Also called INT-747, 6α-ethyl chenodeoxycholic acid, 6-ECDCA

  • OCA 10 mgDrug

    Also called INT-747, 6α-ethyl chenodeoxycholic acid, 6-ECDCA

  • OCA 25 mgDrug

    Also called INT-747, 6α-ethyl chenodeoxycholic acid, 6-ECDCA

Study groups in NCT01933503
Study groupRoleWhat they receive
OCA 5 mgExperimentalOCA 5 mg, 1 mg by mouth followed by 2 days of no investigational product (IP); then OCA 5 mg by mouth for 14 days.
Receives: Drug: OCA 5 mg
OCA 10 mgExperimentalOCA 10 mg, 1 mg by mouth followed by 2 days of no investigational product (IP); then OCA 10 mg by mouth for 14 days.
Receives: Drug: OCA 10 mg
OCA 25 mgExperimentalOCA 25 mg, 1 mg by mouth followed by 2 days of no investigational product (IP); then OCA 25 mg by mouth for 14 days.
Receives: Drug: OCA 25 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum concentration (Cmax observed)

    Maximum concentration (observed) following single and multiple doses of OCA 5 mg, 10 mg, and 25 mg

    Measured: 3 days - single dose, 33 days - Multi dose

  2. Time to maximum concentration (tmax)

    Time to maximum concentration (tmax)

    Measured: 3 days - single dose, 33 days - Multi dose

  3. Area under the concentration vs. time curve (AUCt)

    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

    Measured: 3 days - single dose, 33 days - Multi dose

  4. Area under the concentration vs. time curve from time 0 to 24 hours (AUC0-24)

    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

    Measured: 24 hours

  5. The ratio of each conjugate to OCA

    The ratio of each conjugate to OCA for exposure PK parameters for both single and multiple dose assessments.

    Measured: 3 days - single dose, 33 days - Multi dose

  6. Accumulation ratios (Rac) based on AUC, Cmax and Cmin

    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

    Measured: 17 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2013 (estimated)
  2. Study startOct 2013
  3. Primary completionNov 2013
  4. Study completionNov 2013

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01933503
Sponsor's protocol ID
747-105
Status last verified
Dec 2013
First submitted
28 Aug 2013
Last updated
5 Dec 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30144429

  • 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.

    PubMed 27743502

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OCA 5 mg, 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 0 inclusion and 19 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 5 Dec 2013. 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 observed) (time frame: 3 days - single dose, 33 days - Multi dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01933503, which also lists 2 linked publications.

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 5 Dec 2013.

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