Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine 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 Fluconazole and Quinidine on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03610945
• Other study ID #: EDP 305-007
• Status: Completed
• Phase: Phase 1
• Start date: July 19, 2018
• Est. completion date: August 21, 2018

Study information

• Verified date: December 2018
• 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 fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 21, 2018
• Est. primary completion date: August 15, 2018
• 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.

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Fluconazole
Subjects will receive fluconazole once daily from Day 5 to Day 18
• Quinidine
Subjects will receive quinidine twice daily from Day 5 to Day 12
• EDP-305
Subjects will receive a single dose of EDP-305 on Day 1 and Day 14
• EDP-305
Subjects will receive a single dose of EDP-305 on Day 1 and Day 8

Locations

Country	Name	City	State
United States	Pharmaceutical Research Associates, Inc.,	Salt Lake City	Utah

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 fluconazole		Up to 19 days
Primary	AUC of EDP-305 with and without coadministration with fluconazole		Up to 19 days
Primary	Cmax of EDP-305 with and without coadministration with quinidine		Up to 13 days
Primary	AUC of EDP-305 with and without coadministration with quinidine		Up to 13 days
Secondary	Safety measured by adverse events		Up to 25 days