NCT03187496

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

A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-305 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Human Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• NASH

Interventions

Type	Name	Description
DRUG	Midazolam	Each subject will receive midazolam on Days 1 and 12.
DRUG	Caffeine	Each subject will receive caffeine on Days 1 and 12.
DRUG	Rosuvastatin	Each subject will receive rosuvastatin on Days 2 and 13.
DRUG	EDP-305	Each subject will receive EDP-305 on Days 5 through 15.

Timeline

• Start date: 2017-05-11
• Primary completion: 2017-06-01
• Completion: 2017-06-14
• First posted: 2017-06-15
• Last updated: 2017-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study