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Drug Drug Interaction Study for EYP001 With Entecavir

NCT03469583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-07-26

No results posted yet for this study

Summary

This is a Phase 1, single-center, open-label, three subsequent dosing periods study to evaluate the drug-drug-interaction (DDI), pharmaco-kinetics (PK) and pharmacodynamics (PD), safety, and tolerability of a single dose of EYP100a combined with ETV in healthy men and women dosed in the morning under fasted conditions.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

EYP001

EYP001 self administered capsules, morning, with non carbonated water

DRUG

Entecavir 1 MG

Entecavir self administered tablets, morning, with non carbonated water

Sponsors & Collaborators

  • CPR Pharma Services Pty Ltd, Australia

    collaborator INDUSTRY

  • Enyo Pharma

    lead INDUSTRY

Principal Investigators

  • Angela Molga, M.D. FRACP · CMAX - Clinical Research Pty Ltd, Level 5, 18a North Terrace, Adelaide, South Australia, 5000, Australia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2018-06-20
Completion
2018-07-20

Countries

  • Australia

Study Locations

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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 NCT03469583 on ClinicalTrials.gov