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

Sponsor

Enanta Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03755778

Collaborator

Pharmaceutical Research Associates (Other)

Enrollment

Location

Arms

1.9

Actual Duration (Months)

37.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
RSV Infection	Drug: EDP-938 Drug: EDP-938 Drug: EDP-938 Drug: Itraconazole Drug: Rifampin Drug: Quinidine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

3-Part Single Group study3-Part Single Group study

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Actual Study Start Date :

Nov 29, 2018

Actual Primary Completion Date :

Jan 21, 2019

Actual Study Completion Date :

Jan 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EDP-938 and itraconazole interaction (Part 1)	Drug: EDP-938 Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 1) Drug: Itraconazole Subjects will receive itraconazole once daily from Day 5 to Day 18
Experimental: EDP-938 and rifampin interaction (Part 2)	Drug: EDP-938 Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 2) Drug: Rifampin Subjects will receive rifampin once daily from Day 5 to Day 16
Experimental: EDP-938 and quinidine interaction (Part 3)	Drug: EDP-938 Subjects will receive EDP-938 once daily on Day 1 and 8 (Part 3) Drug: Quinidine Subjects will receive quinidine once daily from Day 5 to Day 12

Arm

Intervention/Treatment

Experimental: EDP-938 and itraconazole interaction (Part 1)

Drug: EDP-938

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

Drug: Itraconazole

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

Experimental: EDP-938 and rifampin interaction (Part 2)

Drug: EDP-938

Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 2)

Drug: Rifampin

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

Experimental: EDP-938 and quinidine interaction (Part 3)

Drug: EDP-938

Subjects will receive EDP-938 once daily on Day 1 and 8 (Part 3)

Drug: Quinidine

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Safety measured by adverse events [Up to 25 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.
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.

Exclusion Criteria:

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.
Participation in a clinical trial within 30 days prior to the first dose of study drug.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pharmaceutical Research Associates, Inc.,	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

Enanta Pharmaceuticals
Pharmaceutical Research Associates

Investigators

Study Director: Enanta Pharmaceuticals, Enanta Pharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Enanta Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03755778

Other Study ID Numbers:

EDP 938-003

First Posted:

Nov 28, 2018

Last Update Posted:

Jun 14, 2019

Last Verified:

Oct 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Enanta Pharmaceuticals

drug-drug interaction

Additional relevant MeSH terms:

Respiratory Syncytial Virus Infections

Itraconazole

Rifampin

Quinidine

Study Results

No Results Posted as of Jun 14, 2019