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Enzyme Inducer

Darigabat Followed by Darigabat + Carbamazepine for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Cerevel Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment period 1: 15 minutes pre-dose on day 1 and up to 48 hours post dose; treatment period 2: 15 minutes pre-dose on day 16 and up to 48 hours post dose

Awards & highlights

Study Summary

This trial studies the effect of a drug (carbamazepine) on the way another drug (darigabat) is processed in the body of healthy adults.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment period 1: 15 minutes pre-dose on day 1 and up to 48 hours post dose; treatment period 2: 15 minutes pre-dose on day 16 and up to 48 hours post dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~treatment period 1: 15 minutes pre-dose on day 1 and up to 48 hours post dose; treatment period 2: 15 minutes pre-dose on day 16 and up to 48 hours post dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment period 1: 15 minutes pre-dose on day 1 and up to 48 hours post dose; treatment period 2: 15 minutes pre-dose on day 16 and up to 48 hours post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUCinf) of Darigabat

Area Under the Plasma Concentration-time Curve up to the Last Specified Sampling Time (AUC0-t) of Darigabat

Maximum Observed Plasma Concentration (Cmax) of Darigabat

Secondary outcome measures

Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)

Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Darigabat Followed by Darigabat + CarbamazepineExperimental Treatment2 Interventions

Participants will receive darigabat tablet orally once on Day 1 of Treatment Period 1. Participants will receive carbamazepine tablets, titrated up to a steady-state dose, orally, twice daily (BID) from Day 1 to 17 along with the darigabat tablet orally once on Day 16 of Treatment Period 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Darigabat

2023

Completed Phase 1

~30

Carbamazepine

2016

Completed Phase 4

~2690

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor

34 Previous Clinical Trials

5,682 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation accept subject enrollees of a certain age or older?

"The lower bound for patient eligibility is 18 years old, while the upper cap is set at 55."

Answered by AI

Who is eligible to take part in this experiment?

"Those wishing to be considered for this medical trial must meet the criteria of being within 18 and 55 years old, with no existing health conditions. 15 participants are currently needed."

Answered by AI

Have the FDA approved any combination of Darigabat and Carbamazepine for medical use?

"Our team assessed the safety of Darigabat Followed by Darigabat + Carbamazepine to be low, due to its Phase 1 status which implies limited evidence for efficacy and safety."

Answered by AI

Is the research project still open to volunteers?

"Affirmative, clinicaltrials.gov provides evidence that this research endeavour is actively enrolling patients. It was initially posted on April 17th 2023 and modified most recently on May 19th 2023. This trial seeks to enrol 15 individuals from a single healthcare facility."

Answered by AI

How many participants are eligible to join this research study?

"Affirmative. Clinicaltrials.gov shows that this research is actively seeking candidates, having been initially posted on April 17th 2023 and updated as recently as May 19th 2023. 15 volunteers are needed across a single site to complete the trial's requirements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Open-label Trial to Evaluate the Effect Carbamazepine on Darigabat Pharmacokinetics in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05824143.