Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects

Hepatitis B Clinical Trial

Official title:

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, and Quinidine on the Pharmacokinetics and Safety of EDP-514 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783753
• Other study ID #: EDP 514-003
• Status: Completed
• Phase: Phase 1
• Start date: November 5, 2020
• Est. completion date: July 9, 2021

Study information

• Verified date: August 2021
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 9, 2021
• Est. primary completion date: June 28, 2021
• 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.

• Male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive

• Female subjects who are heterosexually active and of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-514.

• Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg.

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 clinically significant active infection.

• A positive urine drug screen at Screening or Day -1.

• Current tobacco smokers or use of tobacco products within 3 months prior to Screening.

• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).

• Clinically significant laboratory abnormalities at screening or Day -1, as determined by the Investigator (including but not limited to hypokalemia, hypocalcemia, or hypomagnesemia for Part 3 participants).

• History of regular alcohol consumption

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

For Part 2 (Carbamazepine) participants:

• Participants of Asian ancestry, given association of carbamazepine and severe rash (Stevens Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) with HLA-B 1502 in this population.

• Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Drug:
• EDP-514
Subjects will receive EDP-514 on Days 1 and 14
• EDP-514
Subjects will receive EDP-514 on Days 1 and 23
• EDP-514
Subjects will receive EDP-514 on Days 1 and 8
• Itraconazole
Subjects will receive itraconazole QD for 14 days
• Carbamazepin
Subjects will receive carbamazepine BID for 23 days
• Quinidine
Subjects will receive quinidine BID for 8 days

Locations

Country	Name	City	State
United States	Pharmaceutical Research Association	Lenexa	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals	PRA Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of EDP-514 with and without coadministration with itraconazole		up to 19 days
Primary	AUC of EDP-514 with and without coadministration with itraconazole		19 days
Primary	Cmax of EDP-514 with and without coadministration with carbamazepine		up to 28 days
Primary	AUC of EDP-514 with and without coadministration with carbamazepine		up to 28 days
Primary	Cmax of EDP-514 with and without coadministration with quinidine		up to 13 days
Primary	AUC of EDP-514 with and without coadministration with quinidine		up to 13 days
Secondary	Safety measured by adverse events		up to 34 days