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Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03213145
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : November 6, 2017
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 itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: intraconazole Drug: Rifampin 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 Itraconazole and Rifampin on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers
Actual Study Start Date : July 11, 2017
Actual Primary Completion Date : August 10, 2017
Actual Study Completion Date : September 7, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
Drug Information available for: Rifampin

Arm Intervention/treatment
Experimental: Part 1 Drug: intraconazole
Subjects will receive itraconazole once daily from Day 5 through Day18

Drug: EDP 305
Subjects will receive EDP 305 once daily on Day 1 and Day 14

Experimental: Part 2 Drug: Rifampin
Subjects will receive rifampin once daily from Day 5 through Day 16

Drug: EDP 305
Subjects will receive EDP 305 once daily on Day 1 and Day 14




Primary Outcome Measures :
  1. Cmax of EDP-305 with and without coadministration with itraconazole [ Time Frame: Up to 19 days ]
  2. AUC of EDP-305 with and without coadministration with itraconazole [ Time Frame: Up to 19 days ]
  3. Cmax of EDP-305 with and without coadministration with rifampin [ Time Frame: Up to 17 days ]
  4. AUC of EDP-305 with and without coadministration with rifampin [ Time Frame: Up to 17 days ]

Secondary Outcome Measures :
  1. Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis). [ Time Frame: Up to 19 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.

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): NCT03213145


Locations
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United States, Kansas
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Enanta Pharmaceuticals
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Ind

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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03213145     History of Changes
Other Study ID Numbers: EDP 305-005
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: July 2017

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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
Itraconazole
Rifampin
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 CYP3A Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers