Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects
Study Details
Study Description
Brief Summary
A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: EDP-235, midazolam, rosuvastatin and caffeine Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days |
Drug: EDP-235
Subjects will receive EDP-235 once daily on Days 5-15
Drug: Midazolam
Subjects will receive midazolam once daily on Days 1 and 12
Drug: Rosuvastatin
Subjects will receive rosuvastatin once daily on Days 2 and 13
Drug: Caffeine
Subjects will receive caffeine once daily on Days 1 and 12
|
Outcome Measures
Primary Outcome Measures
- Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235 [Up to 17 Days]
- AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235 [Up to 17 Days]
Secondary Outcome Measures
- Safety measured by adverse events [Up to 22 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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An informed consent document signed and dated by the subject
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Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive
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Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
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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:
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Clinically relevant evidence or history of illness or disease
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Pregnant or nursing females
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History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
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A positive urine drug screen at Screening or Day -1
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Current tobacco smokers or use of tobacco within 3 months prior to Screening.
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Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
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History of regular alcohol consumption
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Participation in a clinical trial within 30 days prior to the first dose of study drug
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History of drug allergy to midazolam, caffeine, or rosuvastatin
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | ICON, plc. | Salt Lake City | Utah | United States | 84124 |
Sponsors and Collaborators
- Enanta Pharmaceuticals, Inc
Investigators
- Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EDP 235-003