A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine a… (NCT06847464) | Clinical Trial Compass
CompletedPhase 1
A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.
United States48 participantsStarted 2025-01-27
Plain-language summary
The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of EDP-323 in healthy adult participants. Each participant's duration in the study will be dependent upon which study part they are enrolled.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 65 years, inclusive.
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of50 kg
* Female subjects 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-323. 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 exceeding protocol limits
* Participation in a clinical trial within 28 days prior to the first dose of study drug
* 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 \>9…
What they're measuring
1
Cmax of EDP-323 with and without coadministration with Itraconazole
Timeframe: Day 1 through Day 19
2
AUC of EDP-323 with and without coadministration with Itraconazole
Timeframe: Day 1 through Day 19
3
Cmax of EDP-323 with and without coadministration with Carbamazepine
Timeframe: Day 1 through Day 28
4
AUC of EDP-323 with and without coadministration with Carbamazepine
Timeframe: Day 1 through Day 28
5
Cmax of EDP-323 with and without coadministration with Quinidine
Timeframe: Day 1 through Day 13
6
AUC of EDP-323 with and without coadministration with Quinidine
Timeframe: Day 1 through Day 13
7
Cmax of EDP-323 with and without coadministration with fluconazole
Timeframe: Day 1 through Day 19
8
AUC of EDP-323 with and without coadministration with fluconazole