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Two-way Interaction Between Alisporivir and EDP239

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02173574
Recruitment Status : Completed
First Posted : June 25, 2014
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: DEB025 Drug: EDP239 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Open-Label Single Arm Cohort Drug: DEB025
Drug: EDP239


Outcome Measures
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Primary Outcome Measures :
  1. Area Under the Plasma Concentration-time Curve (AUC) [ 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 ]
    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

  2. Adverse Events [ 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 ]
    AEs are reviewed on an ongoing basis

  3. Safety Labs [ 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 ]
    Laboratory samples will be assessed for the following: hematology, blood chemistry, and urinalysis

  4. Plasma Pharmacokinetics (PK) of DEB025 and EDP239: Observed Maximum Plasma Concentration Following Drug Administration at Steady State (Cmax, ss) [ 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 ]
    Cmax,ss was directly determined from the raw plasma concentration-time data.

  5. Vital Signs [ 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 ]
    Blood pressure and pulse rate will be assessed for safety.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173574


Locations
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Germany
Investigative Site
Berlin, Germany, 14050
Sponsors and Collaborators
Enanta Pharmaceuticals, Inc
Investigators
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Study Director: Enanta Pharmaceuticals Enanta Pharmaceuticals, Inc
More Information
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Responsible Party: Enanta Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT02173574    
Other Study ID Numbers: CDEB025A2119
2013-004287-59 ( EudraCT Number )
First Posted: June 25, 2014    Key Record Dates
Last Update Posted: January 9, 2015
Last Verified: January 2015
Keywords provided by Enanta Pharmaceuticals, Inc:
Hepatitis C Virus, Viral, Antiviral, Infection, Infectious disease, alisporivir, EDP239, DEB025
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections