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Two-way Interaction Between Alisporivir and EDP239

Primary Purpose

Hepatitis C Virus

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
DEB025
EDP239
Sponsored by
Enanta Pharmaceuticals, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus focused on measuring Hepatitis C Virus, Viral, Antiviral, Infection, Infectious disease, alisporivir, EDP239, DEB025

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-Label Single Arm Cohort

Arm Description

Outcomes

Primary Outcome Measures

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
Adverse Events
AEs are reviewed on an ongoing basis
Safety Labs
Laboratory samples will be assessed for the following: hematology, blood chemistry, and urinalysis
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.
Vital Signs
Blood pressure and pulse rate will be assessed for safety.

Secondary Outcome Measures

Full Information

First Posted
June 20, 2014
Last Updated
January 7, 2015
Sponsor
Enanta Pharmaceuticals, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02173574
Brief Title
Two-way Interaction Between Alisporivir and EDP239
Official Title
An Open-label, Two Part Investigation of the Pharmacokinetics, Safety, and Tolerability of Alisporivir and EDP239 When Co-administered to Healthy Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enanta Pharmaceuticals, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus
Keywords
Hepatitis C Virus, Viral, Antiviral, Infection, Infectious disease, alisporivir, EDP239, DEB025

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Single Arm Cohort
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DEB025
Intervention Type
Drug
Intervention Name(s)
EDP239
Primary Outcome Measure Information:
Title
Area Under the Plasma Concentration-time Curve (AUC)
Description
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
Title
Adverse Events
Description
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
Title
Safety Labs
Description
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
Title
Plasma Pharmacokinetics (PK) of DEB025 and EDP239: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax, ss)
Description
Cmax,ss was directly determined from the raw plasma concentration-time data.
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
Title
Vital Signs
Description
Blood pressure and pulse rate will be assessed for safety.
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enanta Pharmaceuticals
Organizational Affiliation
Enanta Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Two-way Interaction Between Alisporivir and EDP239

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