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Open-label Trial to Evaluate the Effect Carbamazepine on Darigabat Pharmacokinetics in Healthy Adult Participants

NCT05824143 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-08-03

No results posted yet for this study

Summary

The primary purpose of the study is to evaluate the effect of increased metabolizing enzyme (cytochrome P450 \[CYP\] 3A4) due to carbamazepine, a strong CYP3A4 inducer, on the pharmacokinetics (PK) of darigabat in healthy adult participants.

Conditions

  • Healthy Participants

Interventions

DRUG

Darigabat

Oral tablet

DRUG

Carbamazepine

Oral tablets

Sponsors & Collaborators

  • Cerevel Therapeutics, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-17
Primary Completion
2023-07-07
Completion
2023-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05824143 on ClinicalTrials.gov