Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects

Phase 1

Completed

• Conditions: RSV Infection
• Interventions: Drug: EDP-938; Drug: Cyclosporine; Drug: Prednisone

• Registration Number: NCT03750383
• Lead Sponsor: Enanta Pharmaceuticals, Inc

Brief Summary

A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-11-02
• Study First Submitted: 2018-11-08
• Primary Completion: 2018-11-17
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-23
• Study Completion: 2018-12-13
• Last Update Submitted: 2019-02-10
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EDP-938 and cyclosporine interaction (Part 1)	EDP-938	-
EDP-938 and cyclosporine interaction (Part 1)	Cyclosporine	-
EDP-938 and prednisone interaction (Part 2)	Prednisone	-
EDP-938 and prednisone interaction (Part 2)	EDP-938	-

Primary Outcome Measures

Name	Time	Method
AUC of EDP-938 with and without coadministration with prednisone	Up to 21 days
Cmax of EDP-938 with and without coadministration with prednisone	Up to 21 days
Cmax of EDP-938 with and without coadministration with cyclosporine	Up to 12 days
AUC of EDP-938 with and without coadministration with cyclosporine	Up to 12 days

Secondary Outcome Measures

Name	Time	Method
Safety measured by adverse events	Up to 21 days

Trial Locations

Locations (1)

Pharmaceutical Research Associates, Inc.,; 🇺🇸 Lenexa, Kansas, United States