Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Enanta Pharmaceuticals, Inc
• Treatments: Caffeine; Midazolam; Rosuvastatin Calcium

Criteria

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-235. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

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

• History of drug allergy to midazolam, caffeine, or rosuvastatin