Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers

Completed · Phase 1

Conditions studied: NASH - Nonalcoholic Steatohepatitis

In brief

This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.

Key facts

Study ID

NCT03213145

Run by

Enanta Pharmaceuticals, Inc

People needed

48

Starts

2017-07-11

Expected to finish

2017-09-07

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.
• Female subjects must be of non-childbearing potential.

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.

Where it is running

• Pharmaceutical Research Associates, Inc., — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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