Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.
Study Details
Study Description
Brief Summary
A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: EDP-235 and Itraconazole interaction (Part 1) Subjects will receive EDP-235 and Itraconazole on respective dosing days |
Drug: EDP-235
Subjects will receive EDP-235 on Days 1 and 14
Drug: Itraconazole
Subjects will receive itraconazole QD Days 5-18
|
Experimental: EDP-235 and Carbamazepine interaction (Part 2) Subjects will receive EDP-235 and Carbamazepine on respective dosing days |
Drug: EDP-235
Subjects will receive EDP-235 on Days 1 and 23
Drug: Carbamazepine
Subjects will receive carbamazepine BID Days 5-23 and Days 24-27
|
Experimental: EDP and Quinidine interaction (Part 3) Subjects will receive EDP-235 and Quinidine on respective dosing days |
Drug: EDP-235
Subjects will receive EDP-235 on Days 1 and 8
Drug: Quinidine
Subjects will receive quinidine BID Days 5-12
|
Outcome Measures
Primary Outcome Measures
- Cmax of EDP-235 with and without coadministration with Itraconazole [Day 1 through Day 19]
- AUC of EDP-235 with and without coadministration with Itraconazole [Day 1 through Day 19]
- Cmax of EDP-235 with and without coadministration with Carbamazepine [Day 1 through Day 26]
- AUC of EDP-235 with and without coadministration with Carbamazepine [Day 1 through Day 26]
- Cmax of EDP-235 with and without coadministration with Quinidine [Day 1 through Day 13]
- AUC of EDP-235 with and without coadministration with Quinidine [Day 1 through Day 13]
Secondary Outcome Measures
- Safety measured by adverse events [Up to 34 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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For Part 2 participants:
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Participants of Asian ancestry, given association of carbamazepine and severe rash (Stevens-Johnson Syndrome [SJS and Toxic Epidermal Necrolysis [TEN]) with HLA-B 1502 in this population
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Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.
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For Part 2 and Part 3 participants, the following cardiovascular abnormalities:
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QRS duration >110 ms
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Incomplete right bundle branch block or any complete bundle branch block
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Heart rate <40 or >90 beats per minute (per vital sign capture while rested)
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History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
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Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome
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PR interval >220 ms or any 2nd or 3rd degree AV block
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Ventricular pre-excitation
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History of drug allergy to itraconazole or other azole antifungals; history of drug allergy to carbamazepine or carboxamide derivatives [e.g. oxcarbazepine]; known hypersensitivity to drugs structurally related to carbamazepine [e.g.: tricyclic antidepressants] or any of its excipients);history or known hypersensitivity to mefloquine, quinine, or quinidine
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | ICON, plc. | Lenexa | Kansas | United States | 66219 |
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 235-002