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

RSV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750383
• Other study ID #: EDP 938-002
• Status: Completed
• Phase: Phase 1
• Start date: November 2, 2018
• Est. completion date: December 13, 2018

Study information

• Verified date: October 2018
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 13, 2018
• Est. primary completion date: November 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• RSV Infection

Intervention

Drug:
• EDP-938
Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1)
• EDP-938
Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2)
• Cyclosporine
Subjects will receive one dose of cyclosporine on Day 5
• Prednisone
Subjects will receive prednisone once daily from Day 5 to Day 14

Locations

Country	Name	City	State
United States	Pharmaceutical Research Associates, Inc.,	Lenexa	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals	Pharmaceutical Research Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of EDP-938 with and without coadministration with cyclosporine		Up to 12 days
Primary	AUC of EDP-938 with and without coadministration with cyclosporine		Up to 12 days
Primary	Cmax of EDP-938 with and without coadministration with prednisone		Up to 21 days
Primary	AUC of EDP-938 with and without coadministration with prednisone		Up to 21 days
Secondary	Safety measured by adverse events		Up to 21 days