Status:
COMPLETED
Drug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Conditions:
RSV Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04871724
Start Date
March 12 2021
End Date
April 16 2021
Last Update
May 4 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pharmaceutical Research Associates, Inc.,
Salt Lake City, Utah, United States, 84124