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

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ClinicalTrials.gov Identifier: NCT04783753
Recruitment Status : Completed
First Posted : March 5, 2021
Last Update Posted : August 16, 2021
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: EDP-514 Drug: Itraconazole Drug: Carbamazepin Drug: Quinidine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 5, 2020
Actual Primary Completion Date : June 28, 2021
Actual Study Completion Date : July 9, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: EDP-514 and Itraconazole interaction (Part 1) Drug: EDP-514
Subjects will receive EDP-514 on Days 1 and 14

Drug: Itraconazole
Subjects will receive itraconazole QD for 14 days

Experimental: EDP-514 and Carbamazepine interaction (Part 2) Drug: EDP-514
Subjects will receive EDP-514 on Days 1 and 23

Drug: Carbamazepin
Subjects will receive carbamazepine BID for 23 days

Experimental: EDP-514 and Quinidine interaction (Part 3) Drug: EDP-514
Subjects will receive EDP-514 on Days 1 and 8

Drug: Quinidine
Subjects will receive quinidine BID for 8 days




Primary Outcome Measures :
  1. Cmax of EDP-514 with and without coadministration with itraconazole [ Time Frame: up to 19 days ]
  2. AUC of EDP-514 with and without coadministration with itraconazole [ Time Frame: 19 days ]
  3. Cmax of EDP-514 with and without coadministration with carbamazepine [ Time Frame: up to 28 days ]
  4. AUC of EDP-514 with and without coadministration with carbamazepine [ Time Frame: up to 28 days ]
  5. Cmax of EDP-514 with and without coadministration with quinidine [ Time Frame: up to 13 days ]
  6. AUC of EDP-514 with and without coadministration with quinidine [ Time Frame: up to 13 days ]

Secondary Outcome Measures :
  1. Safety measured by adverse events [ Time Frame: up to 34 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04783753


Locations
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United States, Kansas
Pharmaceutical Research Association
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
Enanta Pharmaceuticals
PRA Health Sciences
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc
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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04783753    
Other Study ID Numbers: EDP 514-003
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: August 16, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enanta Pharmaceuticals:
drug-drug interaction
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Itraconazole
Quinidine
Carbamazepine
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents