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

NCT03213145 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 305-005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

drug-drug interaction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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

Study Arms (2)

Part 1

EXPERIMENTAL

Drug: intraconazole; Drug: EDP 305

Part 2

EXPERIMENTAL

Drug: Rifampin; Drug: EDP 305

Interventions

intraconazole DRUG

Subjects will receive itraconazole once daily from Day 5 through Day18

Part 1

Rifampin DRUG

Subjects will receive rifampin once daily from Day 5 through Day 16

Part 2

EDP 305 DRUG

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

Part 1; Part 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Rifampin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Ind

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2-Part Single Group study.

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 11, 2017
• Study Start: July 11, 2017
• Primary Completion: August 10, 2017
• Study Completion: September 7, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-07

Locations

US (1)