Hepatic Impairment Trial of Obeticholic Acid

NCT01904539 ↗

Phase 1 Completed 32 enrolled Intercept Pharmaceuticals

Non-randomizedSingle-groupOpen-labelBasic science

Summary

This is a phase 1 study to evaluate the safety of a single 10 mg dose of obeticholic acid (OCA) in healthy volunteers and patients with liver disease.

Timeline

Start: 2013-06
Primary completion: 2013-10
Completion: 2013-10

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Obeticholic Acid	Small molecule	10 mg	—

Indications

No indication recorded.