Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects

NCT03755778 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 938-003
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects

Conditions

RSV Infection

Keywords

drug-drug interaction

Outcome Measures

Primary Outcomes (6)

• Cmax of EDP-938 with and without coadministration with itraconazole

  Up to 19 days

• AUC of EDP-938 with and without coadministration with itraconazole

  Up to 19 days

• Cmax of EDP-938 with and without coadministration with rifampin

  Up to 17 days

• AUC of EDP-938 with and without coadministration with rifampin

  Up to 17 days

• Cmax of EDP-938 with and without coadministration with quinidine

  Up to 13 days

• AUC of EDP-938 with and without coadministration with quinidine

  Up to 13 days

Secondary Outcomes (1)

• Safety measured by adverse events

  Up to 25 days

Study Arms (3)

EDP-938 and itraconazole interaction (Part 1)

EXPERIMENTAL

Drug: EDP-938; Drug: Itraconazole

EDP-938 and rifampin interaction (Part 2)

EXPERIMENTAL

Drug: EDP-938; Drug: Rifampin

EDP-938 and quinidine interaction (Part 3)

EXPERIMENTAL

Drug: EDP-938; Drug: Quinidine

Interventions

EDP-938 DRUG

Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 1)

EDP-938 and itraconazole interaction (Part 1)

Itraconazole DRUG

Subjects will receive itraconazole once daily from Day 5 to Day 18

EDP-938 and itraconazole interaction (Part 1)

Rifampin DRUG

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

EDP-938 and rifampin interaction (Part 2)

Quinidine DRUG

Subjects will receive quinidine once daily from Day 5 to Day 12

EDP-938 and quinidine interaction (Part 3)

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.
• Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
• Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.

You may not qualify if:

• Clinically relevant evidence or history of illness or disease.
• For Part 3 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
• 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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead
• Pharmaceutical Research Associates: collaborator

Study Sites (1)

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

EDP-938; Itraconazole; Rifampin; Quinidine

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Cinchona Alkaloids; Alkaloids; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring

Study Officials

• Enanta Pharmaceuticals

  Enanta Pharmaceuticals, Inc

  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: 3-Part Single Group study

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: November 29, 2018
• Primary Completion: January 21, 2019
• Study Completion: January 27, 2019
• Last Updated: June 14, 2019

Record last verified: 2018-10

Locations

US (1)