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Completed

NCT Number: NCT03750383

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

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

Completed

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EDP-938

Drug

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

cyclosporine

Drug

Subjects will receive one dose of cyclosporine on Day 5

Prednisone

Drug

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

Primary outcomes

  1. Cmax of EDP-938 with and without coadministration with cyclosporine

    Time frame: Up to 12 days

  2. AUC of EDP-938 with and without coadministration with cyclosporine

    Time frame: Up to 12 days

  3. Cmax of EDP-938 with and without coadministration with prednisone

    Time frame: Up to 21 days

  4. AUC of EDP-938 with and without coadministration with prednisone

    Time frame: Up to 21 days

Secondary outcomes

  1. Safety measured by adverse events

    Time frame: Up to 21 days

Sponsors and collaborators

Lead sponsor

Enanta Pharmaceuticals, Inc

Industry

Collaborators

  • Pharmaceutical Research Associates

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 23, 2018
Registry last updated
Feb 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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