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

NASH - Nonalcoholic Steatohepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213145
• Other study ID #: EDP 305-005
• Status: Completed
• Phase: Phase 1
• First received: July 7, 2017
• Last updated: November 2, 2017
• Start date: July 11, 2017
• Est. completion date: September 7, 2017

Study information

• Verified date: July 2017
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 7, 2017
• Est. primary completion date: August 10, 2017
• 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.

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• intraconazole
Subjects will receive itraconazole once daily from Day 5 through Day18
• Rifampin
Subjects will receive rifampin once daily from Day 5 through Day 16
• EDP 305
Subjects will receive EDP 305 once daily on Day 1 and Day 14

Locations

Country	Name	City	State
United States	Pharmaceutical Research Associates, Inc.,	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of EDP-305 with and without coadministration with itraconazole		Up to 19 days
Primary	AUC of EDP-305 with and without coadministration with itraconazole		Up to 19 days
Primary	Cmax of EDP-305 with and without coadministration with rifampin		Up to 17 days
Primary	AUC of EDP-305 with and without coadministration with rifampin		Up to 17 days
Secondary	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