drugset
drugset / Trial / NCT03110276

Study Evaluating Safety, Tolerability and Pharmacokinetics of EYP001a in Healthy Male Subjects

NCT03110276 ↗

Phase 1 Completed 80 enrolled Enyo Pharma PRA Health Sciences · collab
RandomizedSequentialQuadruple-blindTreatment

Summary

The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B. This Phase 1 study is designed primarily to evaluate the single ascending dose (SAD) followed by a multiple ascending dose (MAD) safety, tolerability, and pharmacokinetics of EYP001a in healthy male subjects.

Timeline

Start
2016-08
Primary completion
2017-03
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject EYP001a Unknown 30 mg Oral
Subject EYP001a Unknown 60 mg Oral
Subject EYP001a Unknown 120 mg Oral
Subject EYP001a Unknown 250 mg Oral
Subject EYP001a Unknown 500 mg Oral
Subject EYP001a Unknown 800 mg Oral

Indications

No indication recorded.