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

• Sponsor: Enanta Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03750383
• Collaborator: Pharmaceutical Research Associates (Other)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 35.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
RSV Infection	Drug: EDP-938; Drug: EDP-938; Drug: Cyclosporine; Drug: Prednisone	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: 2-Part Single Group study2-Part Single Group study
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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
• Actual Study Start Date: Nov 2, 2018
• Actual Primary Completion Date: Nov 17, 2018
• Actual Study Completion Date: Dec 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EDP-938 and cyclosporine interaction (Part 1)	Drug: EDP-938; Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1); Drug: Cyclosporine; Subjects will receive one dose of cyclosporine on Day 5
Experimental: EDP-938 and prednisone interaction (Part 2)	Drug: EDP-938; Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2); Drug: Prednisone; Subjects will receive prednisone once daily from Day 5 to Day 14

Outcome Measures

Primary Outcome Measures

1. Cmax of EDP-938 with and without coadministration with cyclosporine [Up to 12 days]

2. AUC of EDP-938 with and without coadministration with cyclosporine [Up to 12 days]

3. Cmax of EDP-938 with and without coadministration with prednisone [Up to 21 days]

4. AUC of EDP-938 with and without coadministration with prednisone [Up to 21 days]

Secondary Outcome Measures

1. Safety measured by adverse events [Up to 21 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pharmaceutical Research Associates, Inc.,	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

• Enanta Pharmaceuticals
• Pharmaceutical Research Associates

Investigators

• Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enanta Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03750383
• Other Study ID Numbers: EDP 938-002
• First Posted: Nov 23, 2018
• Last Update Posted: Feb 12, 2019
• Last Verified: Oct 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Enanta Pharmaceuticals: drug drug interaction study
• Additional relevant MeSH terms: Respiratory Syncytial Virus Infections; Cyclosporine; Prednisone; Cyclosporins

Study Results

No Results Posted as of Feb 12, 2019