Back to resultsDrug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
Primary Purpose
NASH - Nonalcoholic Steatohepatitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fluconazole
Quinidine
EDP-305
EDP-305
Sponsored by
About this trial
This is an interventional basic science trial for NASH - Nonalcoholic Steatohepatitis focused on measuring drug-drug interaction
Eligibility Criteria
Inclusion Criteria:
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
- Female subjects must be of non-childbearing potential.
Exclusion Criteria:
- Clinically relevant evidence or history of illness or disease.
- Pregnant or nursing females.
- History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- A positive urine drug screen at screening or Day -1.
- Current tobacco smokers or use of tobacco within 3 months prior to screening.
- Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
- History of regular alcohol consumption.
- Participation in a clinical trial within 30 days prior to the first dose of study drug.
- Clinically significant electrocardiogram abnormalities or QTcF greater than 450 ms for males and 470 ms for females at either Screening or Day -1 (Part 2 only), or any prior history of QT abnormality.
For Part 2 subjects, the following cardiovascular abnormalities
- QRS duration >110 ms
- Incomplete right bundle branch block or any complete bundle branch block
- Heart rate <40 or >90 beats per minute (per vital sign capture while rested)
- History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
- Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome
- PR interval >220 ms or any 2nd or 3rd degree AV block
- Ventricular pre-excitation
Sites / Locations
- Pharmaceutical Research Associates, Inc.,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
EDP-305 and fluconazole interaction (Part 1)
EDP-305 and quinidine interaction (Part 2)
Arm Description
Outcomes
Primary Outcome Measures
Cmax of EDP-305 with and without coadministration with fluconazole
AUC of EDP-305 with and without coadministration with fluconazole
Cmax of EDP-305 with and without coadministration with quinidine
AUC of EDP-305 with and without coadministration with quinidine
Secondary Outcome Measures
Safety measured by adverse events
Full Information
NCT ID
NCT03610945
First Posted
July 12, 2018
Last Updated
December 4, 2018
Sponsor
Enanta Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT03610945
Brief Title
Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
Official Title
A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole and Quinidine on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
August 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enanta Pharmaceuticals, Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NASH - Nonalcoholic Steatohepatitis
Keywords
drug-drug interaction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
2-Part Single Group study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EDP-305 and fluconazole interaction (Part 1)
Arm Type
Experimental
Arm Title
EDP-305 and quinidine interaction (Part 2)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Description
Subjects will receive fluconazole once daily from Day 5 to Day 18
Intervention Type
Drug
Intervention Name(s)
Quinidine
Intervention Description
Subjects will receive quinidine twice daily from Day 5 to Day 12
Intervention Type
Drug
Intervention Name(s)
EDP-305
Intervention Description
Subjects will receive a single dose of EDP-305 on Day 1 and Day 14
Intervention Type
Drug
Intervention Name(s)
EDP-305
Intervention Description
Subjects will receive a single dose of EDP-305 on Day 1 and Day 8
Primary Outcome Measure Information:
Title
Cmax of EDP-305 with and without coadministration with fluconazole
Time Frame
Up to 19 days
Title
AUC of EDP-305 with and without coadministration with fluconazole
Time Frame
Up to 19 days
Title
Cmax of EDP-305 with and without coadministration with quinidine
Time Frame
Up to 13 days
Title
AUC of EDP-305 with and without coadministration with quinidine
Time Frame
Up to 13 days
Secondary Outcome Measure Information:
Title
Safety measured by adverse events
Time Frame
Up to 25 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
An informed consent document signed and dated by the subject.
Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
Female subjects must be of non-childbearing potential.
Exclusion Criteria:
Clinically relevant evidence or history of illness or disease.
Pregnant or nursing females.
History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
A positive urine drug screen at screening or Day -1.
Current tobacco smokers or use of tobacco within 3 months prior to screening.
Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
History of regular alcohol consumption.
Participation in a clinical trial within 30 days prior to the first dose of study drug.
Clinically significant electrocardiogram abnormalities or QTcF greater than 450 ms for males and 470 ms for females at either Screening or Day -1 (Part 2 only), or any prior history of QT abnormality.
For Part 2 subjects, the following cardiovascular abnormalities
QRS duration >110 ms
Incomplete right bundle branch block or any complete bundle branch block
Heart rate <40 or >90 beats per minute (per vital sign capture while rested)
History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome
PR interval >220 ms or any 2nd or 3rd degree AV block
Ventricular pre-excitation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enanta Pharmaceuticals, Inc
Organizational Affiliation
Enanta Pharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Pharmaceutical Research Associates, Inc.,
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
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