Back to resultsDrug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects
Primary Purpose
RSV Infection
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EDP-938
Fluconazole
Sponsored by
About this trial
This is an interventional treatment trial for RSV Infection focused on measuring drug-drug interaction
Eligibility Criteria
Inclusion 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.
- Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
- Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.
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 history of drug sensitivity or allergy to fluconazole or other azole antifungals
Sites / Locations
- Pharmaceutical Research Associates, Inc.,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EDP-938 and Fluconazole interaction
Arm Description
Outcomes
Primary Outcome Measures
Cmax of EDP-938 with and without coadministration with fluconazole
AUC of EDP-938 with and without coadministration with fluconazole
Secondary Outcome Measures
Safety measured by adverse events
Full Information
NCT ID
NCT04871724
First Posted
April 29, 2021
Last Updated
April 29, 2021
Sponsor
Enanta Pharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT04871724
Brief Title
Drug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects
Official Title
A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
April 16, 2021 (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
A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RSV Infection
Keywords
drug-drug interaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EDP-938 and Fluconazole interaction
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
EDP-938
Intervention Description
Subjects will receive EDP-938 once daily on Days 1 and 14
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Intervention Description
Subjects will receive fluconazole once daily on Days 5 to 18
Primary Outcome Measure Information:
Title
Cmax of EDP-938 with and without coadministration with fluconazole
Time Frame
Up to 19 days
Title
AUC of EDP-938 with and without coadministration with fluconazole
Time Frame
Up to 19 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:
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.
Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.
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 history of drug sensitivity or allergy to fluconazole or other azole antifungals
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 Fluconazole and EDP-938 in Healthy Subjects
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