NCT03110276

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EYP001a in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Enyo Pharma · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a two-part, randomized, double-blind, placebo-controlled study. Healthy male subjects will be randomly assigned to receive EYP001a or placebo. In the SAD part, up to 6 cohorts will receive EYP001a single doses of 30 mg, 60 mg, 120 mg, 250 mg, 500 mg, and 800 mg. In the MAD part, 4 cohorts will receive EYP001a doses of 60, 120, 250 and 500 mg, once daily for 14 days over 15-day period. Each cohort will include 6 active \& 2 placebo subjects. Dose escalation will depend on evaluation of safety parameters. Participation will include up to 21-day screening period followed by dosing period (1 to 15 days). A follow-up evaluation will occur at 6 ± 2 days post final dose. Safety and tolerability will be assessed by monitoring adverse events, laboratory values, ECG parameters, and vital signs.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	EYP001a	10 mg and 100 mg capsules. Number of capsules to be ingested will depend on the dose cohort. Administered orally once daily. Single dose (SAD) or 14 days treatment (MAD).
DRUG	Placebo	Placebo capsules, identical in appearance to the EYP001a 10 mg and 100 mg capsules.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2017-04-12
• Last updated: 2017-04-13