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

NCT03750383 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 938-002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

RSV Infection

Keywords

drug drug interaction study

Outcome Measures

Primary Outcomes (4)

• 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

• Cmax of EDP-938 with and without coadministration with prednisone

  Up to 21 days

• AUC of EDP-938 with and without coadministration with prednisone

  Up to 21 days

Secondary Outcomes (1)

• Safety measured by adverse events

  Up to 21 days

Study Arms (2)

EDP-938 and cyclosporine interaction (Part 1)

EXPERIMENTAL

Drug: EDP-938; Drug: Cyclosporine

EDP-938 and prednisone interaction (Part 2)

EXPERIMENTAL

Drug: EDP-938; Drug: Prednisone

Interventions

EDP-938 DRUG

Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1)

EDP-938 and cyclosporine interaction (Part 1)

Cyclosporine DRUG

Subjects will receive one dose of cyclosporine on Day 5

EDP-938 and cyclosporine interaction (Part 1)

Prednisone DRUG

Subjects will receive prednisone once daily from Day 5 to Day 14

EDP-938 and prednisone interaction (Part 2)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead
• Pharmaceutical Research Associates: collaborator

Study Sites (1)

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

EDP-938; Cyclosporine; Prednisone

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2-Part Single Group study

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 23, 2018
• Study Start: November 2, 2018
• Primary Completion: November 17, 2018
• Study Completion: December 13, 2018
• Last Updated: February 12, 2019

Record last verified: 2018-10

Locations

US (1)