NASH - Nonalcoholic Steatohepatitis Clinical Trial
Official title:
A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole and Quinidine on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers
Verified date | December 2018 |
Source | Enanta Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.
Status | Completed |
Enrollment | 48 |
Est. completion date | August 21, 2018 |
Est. primary completion date | August 15, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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. - Female subjects must be of non-childbearing potential. 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. - Clinically significant electrocardiogram abnormalities or QTcF greater than 450 ms for males and 470 ms for females at either Screening or Day -1 (Part 2 only), or any prior history of QT abnormality. - For Part 2 subjects, the following cardiovascular abnormalities - QRS duration >110 ms - Incomplete right bundle branch block or any complete bundle branch block - Heart rate <40 or >90 beats per minute (per vital sign capture while rested) - History of unexplained syncope, structural heart disease, or clinically significant arrhythmias - 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 - PR interval >220 ms or any 2nd or 3rd degree AV block - Ventricular pre-excitation |
Country | Name | City | State |
---|---|---|---|
United States | Pharmaceutical Research Associates, Inc., | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Enanta Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax of EDP-305 with and without coadministration with fluconazole | Up to 19 days | ||
Primary | AUC of EDP-305 with and without coadministration with fluconazole | Up to 19 days | ||
Primary | Cmax of EDP-305 with and without coadministration with quinidine | Up to 13 days | ||
Primary | AUC of EDP-305 with and without coadministration with quinidine | Up to 13 days | ||
Secondary | Safety measured by adverse events | Up to 25 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
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