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Healthy ParticipantsPhase 1NCT06435923

A Trial to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-Darigabat After a Single Oral Dose in Healthy Male Participants

A Phase 1 study testing [14C]-darigabat in people with Healthy Participants, run by Cerevel Therapeutics, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this trial is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of darigabat, and total radioactivity in plasma and whole blood following administration of a single oral dose of [14C]-darigabat in healthy adult male… Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
[14C]-darigabat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
29 May 2024to 3 Jul 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body mass index of 18.5 to 35.0 kilograms per square meters (kg/m^2), inclusive, and a total body weight ≥50 kg [110 Pounds (lbs)] at Screening.
  • A male participant who is sexually active with a pregnant or a nonpregnant partner of childbearing potential must agree to use a condom during the trial and for 93 days after the dose of investigational medicinal product (IMP). In addition, male participants should not donate sperm for a minimum of 93 days following the dose of IMP.
  • Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.

Who cannot join

  • Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
  • "Yes" responses for any of the following items on the Columbia-Suicide Severity Rating Scale (C-SSRS) (within the individual's lifetime):
  • Suicidal Ideation Item 3 (Active Suicidal Ideation with Any Methods [Not Plan] without Intent to Act)
  • Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan)
  • Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent)
  • Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior) "Yes" responses for any of the following items on the C-SSRS (within past 12 months):
Show all 13Show fewer
  • Suicidal Ideation Item 1 (Wish to be Dead)
  • Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts) Serious risk of suicide in the opinion of the investigator is also exclusionary.
  • Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy.
  • Positive result for human immunodeficiency viruses (HIV) antibody, hepatitis B surface antigen, hepatitis B total core antibody, or hepatitis C antibody with detectable viral Ribonucleic acid (RNA) levels at Screening. Note: Positive or indeterminate test result for hepatitis C antibody should follow with hepatitis C virus polymerase chain reaction (PCR) RNA test. If result is positive, the participant is excluded.
  • Positive drug screen [including cotinine and Tetrahydrocannabinol (THC)] or a positive test for alcohol.
  • Known allergy or hypersensitivity to the IMP, closely related compounds, or any of their specified ingredients.
  • NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Austin, Texas

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Open-Label Trial to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-Darigabat Following a Single Oral Dose in Healthy Adult Male Participants

The primary purpose of this trial is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of darigabat, and total radioactivity in plasma and whole blood following administration of a single oral dose of [14C]-darigabat in healthy adult male participants.

Being tested
[14C]-darigabat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-darigabatDrug

    Also called CVL-865; PF-06372865

    Oral capsule

Study groups in NCT06435923
Study groupRoleWhat they receive
DarigabatExperimentalParticipants will receive a single oral dose of darigabat.
Receives: Drug: [14C]-darigabat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Concentration Time Curve (AUC) from Time Zero to Infinity (AUCinf) of Darigabat

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  2. AUC from Time 0 to the Time of the Last Measured Concentration (AUClast) of Darigabat

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  3. Maximum Observed Plasma Concentration (Cmax) of Darigabat

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  4. Time to Last Quantifiable (Tlast) Concentration of Darigabat

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  5. Time to Maximum Observed Concentration (Tmax) of Darigabat

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  6. Terminal Phase Half-life (t½) of Darigabat

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  7. Apparent Total Clearance After Oral Administration (CL/F) of Darigabat

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  8. Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Darigabat

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  9. Ratio of Plasma AUCinf for Darigabat to Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  10. Ratio of Whole Blood AUCinf for Total Radioactivity to Plasma Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  11. Amount Excreted in Urine (Aeu) of Total Radioactivity

    Urine PK parameters will be assessed.

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  12. Amount Excreted in Feces (Aef) of Total Radioactivity

    Fecal PK parameters will be assessed.

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

Secondary outcomes (8)

  1. Metabolite Profile of [14C]-darigabat in Plasma, Urine and Feces

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  2. Identification of [14C]-darigabat Metabolites Found in Plasma, Urine and Feces

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  3. Structural Elucidation of [14C]-darigabat Metabolites ≥10% of the Total [14C]-darigabat Radioactivity Found in Plasma, Urine and Feces

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  4. Number of Participants with Adverse Events (AEs)

    Measured: Up to Day 16

  5. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values

    Measured: Up to Day 15

  6. Number of Participants with Clinically Significant Changes in Vital Signs

    Measured: Up to Day 15

  7. Number of Participants with Clinically Significant Changes in Laboratory Assessments

    Measured: Up to Day 15

  8. Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results

    Measured: Up to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2024
  2. Study start29 May 2024
  3. Primary completion2 Jul 2024
  4. Study completion3 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06435923
Sponsor's protocol ID
CVL-865-HV-1004
Status last verified
Jul 2024
First submitted
24 May 2024
Last updated
31 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-darigabat in people with Healthy Participants, run by Cerevel Therapeutics, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration Time Curve (AUC) from Time Zero to Infinity (AUCinf) of Darigabat (time frame: Pre-dose and at multiple time points post-dose up to Day 15). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06435923.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.

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