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

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

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.

Study Overview

• Status: Completed
• Conditions: NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: intraconazole; Drug: EDP 305; Drug: Rifampin

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Pharmaceutical Research Associates, Inc.,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: EDP 305; Subjects will receive EDP 305 once daily on Day 1 and Day 14; Drug: Rifampin; Subjects will receive rifampin once daily from Day 5 through Day 16

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of EDP-305 with and without coadministration with itraconazole	Up to 19 days
AUC of EDP-305 with and without coadministration with itraconazole	Up to 19 days
Cmax of EDP-305 with and without coadministration with rifampin	Up to 17 days
AUC of EDP-305 with and without coadministration with rifampin	Up to 17 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc
• Investigators: Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Ind

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): August 10, 2017
• Study Completion (Actual): September 7, 2017

Study Registration Dates

• First Submitted: July 7, 2017
• First Submitted That Met QC Criteria: July 7, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: drug-drug interaction
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin
• Other Study ID Numbers: EDP 305-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No