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Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03610945
Recruitment Status : Completed
First Posted : August 1, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: Fluconazole Drug: Quinidine Drug: EDP-305 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 2-Part Single Group study
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : July 19, 2018
Actual Primary Completion Date : August 15, 2018
Actual Study Completion Date : August 21, 2018


Arm Intervention/treatment
Experimental: EDP-305 and fluconazole interaction (Part 1) Drug: Fluconazole
Subjects will receive fluconazole once daily from Day 5 to Day 18

Drug: EDP-305
Subjects will receive a single dose of EDP-305 on Day 1 and Day 14

Experimental: EDP-305 and quinidine interaction (Part 2) Drug: Quinidine
Subjects will receive quinidine twice daily from Day 5 to Day 12

Drug: EDP-305
Subjects will receive a single dose of EDP-305 on Day 1 and Day 8




Primary Outcome Measures :
  1. Cmax of EDP-305 with and without coadministration with fluconazole [ Time Frame: Up to 19 days ]
  2. AUC of EDP-305 with and without coadministration with fluconazole [ Time Frame: Up to 19 days ]
  3. Cmax of EDP-305 with and without coadministration with quinidine [ Time Frame: Up to 13 days ]
  4. AUC of EDP-305 with and without coadministration with quinidine [ Time Frame: Up to 13 days ]

Secondary Outcome Measures :
  1. Safety measured by adverse events [ Time Frame: Up to 25 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610945


Locations
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United States, Utah
Pharmaceutical Research Associates, Inc.,
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Enanta Pharmaceuticals
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc

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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03610945     History of Changes
Other Study ID Numbers: EDP 305-007
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enanta Pharmaceuticals:
drug-drug interaction
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases
Fluconazole
Quinidine
Quinidine gluconate
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Anti-Arrhythmia Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents