Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.

Completed · Phase 1

Conditions studied: NASH

In brief

A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy human volunteers.

Key facts

Study ID

NCT03187496

Run by

Enanta Pharmaceuticals, Inc

People needed

24

Starts

2017-05-11

Expected to finish

2017-06-14

Last updated by the study team

2017-08-21

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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