Two-way Interaction Between Alisporivir and EDP239

Enanta Pharmaceuticals, Inc42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Virus

Interventions

DEB025DRUG

EDP239DRUG

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Investigative Site

Berlin, Germany

Outcomes

Primary Outcomes

Area Under the Plasma Concentration-time Curve (AUC)

The following PK parameters were determined from the plasma concentration time profile of EDP239 and DEB025 using a non-compartmental method: AUCtau: Area under the plasma concentration-time curve from time zero to the end of the dosing interval AUC0-24: Area under the plasma concentration-time curve from time zero to 24 hours AUClast: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration. AUClast was calculated as the sum of linear trapezoids using non-compartmental analysis. AUCinf: Area under the plasma concentration-time curve from time zero to infinity. AUCinf was calculated by adding AUClast and the value obtained from dividing the last measurable plasma concentration by λz, where λz was determined from automated linear regression of the last three time points with non-zero concentrations in the terminal phase of the log-transformed concentration-time profile

Time frame: EDP239 P1: D7/15/21: 0 (pre), and postdose 1,2,3,4,5,6,8,12hr P2: at D10 pre and postdose at 1,2,3,4,5,6,8,12hr,D11/12/13/14. DEB025 P1: D15/21 at pre and postdose at 1,2,3,4,5,6,8,12hr P2: D3/10(Per2) at pre, 0.5,1,2,4,6,8,12,24,3,48,72,96,120,144,168

Adverse Events

AEs are reviewed on an ongoing basis

Time frame: Part 1: Screening (Day -22 to -2) to Day 35 Part 2: Period 1- Screening (Day -22 to -2) to Day 8 Period 2- Day -1 to 28

Safety Labs

Laboratory samples will be assessed for the following: hematology, blood chemistry, and urinalysis

Time frame: Part 1: Screening (Day -22 to -2), -1, 1, 7, 14, 21 Part 2: Period 1- Screening (Day -22 to -2), Day -1, 8 Period 2- Day -1, 1, 14, 28

Plasma Pharmacokinetics (PK) of DEB025 and EDP239: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax, ss)

Cmax,ss was directly determined from the raw plasma concentration-time data.

Data from ClinicalTrials.gov

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