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

RSV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755778
• Other study ID #: EDP 938-003
• Status: Completed
• Phase: Phase 1
• Start date: November 29, 2018
• Est. completion date: January 27, 2019

Study information

• Verified date: October 2018
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 27, 2019
• Est. primary completion date: January 21, 2019
• 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.

• 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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• RSV Infection

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals	Pharmaceutical Research Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of EDP-938 with and without coadministration with itraconazole		Up to 19 days
Primary	AUC of EDP-938 with and without coadministration with itraconazole		Up to 19 days
Primary	Cmax of EDP-938 with and without coadministration with rifampin		Up to 17 days
Primary	AUC of EDP-938 with and without coadministration with rifampin		Up to 17 days
Primary	Cmax of EDP-938 with and without coadministration with quinidine		Up to 13 days
Primary	AUC of EDP-938 with and without coadministration with quinidine		Up to 13 days
Secondary	Safety measured by adverse events		Up to 25 days