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

NCT03110276 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-04-13

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Enyo Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2017-03-31
Completion
2017-03-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03110276 on ClinicalTrials.gov