Last reviewed · How we verify
NCT01914562
An Open Label Trial to Assess the Effects of Food on the Pharmacokinetic Parameters of Obeticholic Acid (OCA)
Phase 1 trial testing OCA 10 mg in Healthy in 32 participants. Completed in 1 November 2013.
1 November 2013
Quick facts
| Lead sponsor | Intercept Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 32 |
| Start date | 1 August 2013 |
| Primary completion | 1 November 2013 |
| Estimated completion | 1 November 2013 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Intercept Pharmaceuticals — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01914562
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy
Currently open trials in the same condition.
- NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
- NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
- NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
- NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
Other Intercept Pharmaceuticals trials
Trials by the same sponsor.
- NCT06121375 — Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OC · Phase 2, PHASE3 · terminated
- NCT06488911 — To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate · Phase 3 · terminated
- NCT05639543 — FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study · Phase 2 · recruiting
- NCT05239468 — Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC · Phase 2 · completed
- NCT04594694 — Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC · Phase 2 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01914562 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Intercept Pharmaceuticals
- Last refreshed: 7 August 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01914562.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing