Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.

Sponsor
Enanta Pharmaceuticals, Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05594602
Collaborator
(none)
36
1
3
2
18

Study Details

Study Description

Brief Summary

A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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-235 IN HEALTHY PARTICIPANTS
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: EDP-235 and Itraconazole interaction (Part 1)

Subjects will receive EDP-235 and Itraconazole on respective dosing days

Drug: EDP-235
Subjects will receive EDP-235 on Days 1 and 14

Drug: Itraconazole
Subjects will receive itraconazole QD Days 5-18

Experimental: EDP-235 and Carbamazepine interaction (Part 2)

Subjects will receive EDP-235 and Carbamazepine on respective dosing days

Drug: EDP-235
Subjects will receive EDP-235 on Days 1 and 23

Drug: Carbamazepine
Subjects will receive carbamazepine BID Days 5-23 and Days 24-27

Experimental: EDP and Quinidine interaction (Part 3)

Subjects will receive EDP-235 and Quinidine on respective dosing days

Drug: EDP-235
Subjects will receive EDP-235 on Days 1 and 8

Drug: Quinidine
Subjects will receive quinidine BID Days 5-12

Outcome Measures

Primary Outcome Measures

  1. Cmax of EDP-235 with and without coadministration with Itraconazole [Day 1 through Day 19]

  2. AUC of EDP-235 with and without coadministration with Itraconazole [Day 1 through Day 19]

  3. Cmax of EDP-235 with and without coadministration with Carbamazepine [Day 1 through Day 26]

  4. AUC of EDP-235 with and without coadministration with Carbamazepine [Day 1 through Day 26]

  5. Cmax of EDP-235 with and without coadministration with Quinidine [Day 1 through Day 13]

  6. AUC of EDP-235 with and without coadministration with Quinidine [Day 1 through Day 13]

Secondary Outcome Measures

  1. Safety measured by adverse events [Up to 34 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-235. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

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 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

  • For Part 2 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.

  • For Part 2 and Part 3 participants, 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

  • History of drug allergy to itraconazole or other azole antifungals; history of drug allergy to carbamazepine or carboxamide derivatives [e.g. oxcarbazepine]; known hypersensitivity to drugs structurally related to carbamazepine [e.g.: tricyclic antidepressants] or any of its excipients);history or known hypersensitivity to mefloquine, quinine, or quinidine

Contacts and Locations

Locations

Site City State Country Postal Code
1 ICON, plc. Lenexa Kansas United States 66219

Sponsors and Collaborators

  • Enanta Pharmaceuticals, Inc

Investigators

  • Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enanta Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT05594602
Other Study ID Numbers:
  • EDP 235-002
First Posted:
Oct 26, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Enanta Pharmaceuticals, Inc
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022