Two-way Interaction Between Alisporivir and EDP239

Hepatitis C Virus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173574
• Other study ID #: CDEB025A2119
• Secondary ID: 2013-004287-59
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2014
• Last updated: January 7, 2015
• Start date: August 2014
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices (BfArM)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• DEB025

• EDP239

Locations

Country	Name	City	State
Germany	Investigative Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?z, where ?z 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	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	Yes
Primary	Adverse Events	AEs are reviewed on an ongoing basis	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	Yes
Primary	Safety Labs	Laboratory samples will be assessed for the following: hematology, blood chemistry, and urinalysis	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	Yes
Primary	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.	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	Yes
Primary	Vital Signs	Blood pressure and pulse rate will be assessed for safety.	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	Yes