Two-way Interaction Between Alisporivir and EDP239

Enanta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatitis C Virus

Treatments: Drug: DEB025; Drug: EDP239

Study type: Interventional

Funder types: Industry

Identifiers

NCT02173574

CDEB025A2119

2013-004287-59 (EudraCT Number)

Details and patient eligibility

About

The purpose of Part 1 is to inform dose selection for use of alisporivir and EDP239 in combination and obtain initial safety data for co-administration of alisporivir and EDP239 to support future treatment studies in patients. The purpose of Part 2 is to inform the drug-drug interaction potential of EDP239 more broadly and possibly facilitate the interpretation of lower than expected alisporivir concentrations in Part 1, if observed.

Enrollment: 42 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female subjects 18 to 55 years of age
• Body weight at least 50 kg

Exclusion criteria

• Women of child bearing potential
• Tobacco use
• History or evidence of any inherited bilirubin disease or disorder, including not not necessarily limited to Dubin-Johnson Syndrome, Gilbert's syndrome, and Rotor Syndrome

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Open-Label Single Arm Cohort

Experimental group

Treatment:

Drug: DEB025

Drug: EDP239