HealthyPhase 1NCT05123079
Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Participants
A Phase 1 study testing Darigabat in people with Healthy, run by Cerevel Therapeutics, LLC at 1 site in United States.
Trial summary
This is a Phase 1, single-center trial in healthy participants. This is a crossover design, open-label treatment trial with 3 periods, 6 sequences. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Darigabat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 7 Dec 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of nonchildbearing potential and men, ages 18 to 55 years, inclusive.
- Healthy as determined by medical evaluation by the investigator.
- Body mass index of 18.5 to 30.0 kg/m2, inclusive, and a total body weight >50 kg (110 lbs).
- A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use contraception.
- Capable of giving signed informed consent and complying with study requirements.
Who cannot join
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease.
- Serious risk of suicide in the opinion of the investigator.
- History of substance or alcohol-use disorder (excluding nicotine or caffeine) within 12 months prior to signing the ICF.
- Any condition that could possibly affect drug absorption.
- Receipt of SARS-CoV2 vaccine or booster as follows:
- mRNA: within 14 days prior to dosing
Show all 13Show fewer
- Non-mRNA: within 28 days prior to dosing
- Have recently been diagnosed with symptomatic COVID-19 or test positive for COVID-19 within 30 days prior to signing the ICF.
- Taking any prohibited medication prior to randomization or likely to require prohibited concomitant therapy.
- History of HIV, hepatitis B, or hepatitis C infection, or positive result for HIV, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody.
- Positive drug screen (including nicotine and cannabinoids) or a positive test for alcohol.
- Abnormal clinical laboratory test results or vital measurements at Screening.
- Any other abnormal safety findings unless, based on the investigator's judgment, the findings are not medically significant and would not impact the safety of the participant or the interpretation of the trial results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, 3-Period Crossover Trial to Evaluate the Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Adult Participants
This is a Phase 1, single-center trial in healthy participants. This is a crossover design, open-label treatment trial with 3 periods, 6 sequences.
Read the detailed description
The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food on Darigabat.
- Conditions
- Healthy
- Being tested
- Darigabat
- Keywords
- Healthy Volunteer, Bioavailability, Food effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarigabatDrug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fasted (Without Food) | Experimental | Oral Dose Receives: Drug: Darigabat |
| Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fed (With food) | Experimental | Oral Dose Receives: Drug: Darigabat |
| Single Oral Dose of 25 mg administered as 2 x 7.5 and 2 x 5.0 mg tablets, Fasted (Without Food) | Experimental | Oral Dose Receives: Drug: Darigabat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Dose: Peak Plasma Concentrations
Peak Plasma Concentration (Cmax) for Darigabat under fasted conditions
Measured: Day 1 to Day 4
Single Dose: Area under the plasma concentration-time curve
Area under the plasma concentration-time curve (AUC) for Darigabat under fasted conditions
Measured: Day 1 to Day 4
Single Dose: Area under the plasma concentration-time curve from time zero to last concentration measured
Area under the plasma concentration-time curve from time zero to last concentration measured (AUClast) for Darigabat under fasted conditions
Measured: Day 1 to Day 4
Single Dose: Time of Maximum Observed Plasma Concentrations
Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted conditions
Measured: Day 1 to Day 4
Secondary Objective: Single Dose: Peak Plasma Concentrations
Peak Plasma Concentration (Cmax) for Darigabat under fed and fasted conditions
Measured: Day 1 to Day 4
Secondary Objective: Single Dose: Area under the plasma concentration-time curve
Area under the plasma concentration-time curve (AUC) for Darigabat under fed and fasted conditions
Measured: Day 1 to Day 4
Secondary Objective: Single Dose: Area under the plasma concentration-time curve from time zero to infinity
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for CVL-865 under fed and fasted conditions
Measured: Day 1 to Day 4
Secondary Objective: Single Dose: Time of Maximum Observed Plasma Concentrations
Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted and fed conditions
Measured: Day 1 to Day 4
Secondary outcomes (6)
Secondary Outcome (AE)
Number of subjects with reported Treatment Emergent Adverse Events (TEAEs)
Measured: Day 1 to Day 4
Secondary Outcome (ECGs)
Number of subjects with clinically significant changes in Electrocardiograms.
Measured: Day 1 to Day 4
Secondary Outcome (Labs)
Number of subjects with clinically significant changes in laboratory measures.
Measured: Day 1 to Day 4
Secondary Outcome (Vital Signs)
Number of subjects with clinically meaningful changes in vitals signs.
Measured: Day 1 to Day 4
Secondary Outcome (Physical/Neurological Exam)
Number of subjects with clinically significant changes in physical and neurological exams.
Measured: Day 1 to Day 4
Secondary Outcome (C-SSRS)
Changes from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS). The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Measured: Day 1 to Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start2 Nov 2021
- Primary completion21 Nov 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a Phase 1, single-center trial in healthy participants. The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food of Darigabat from a single oral.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerevel Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann M Dandurand, MD, Study director, Cerevel Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123079
- Sponsor's protocol ID
- CVL-865-1002
- Status last verified
- Jan 2022
- First submitted
- 5 Nov 2021
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 3-Period Crossover Trial to Evaluate the Relative Bioavailability and Food Effect Following Single Oral Dose of Darigabat Tablet Formulations in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05123079
- Acronym / sponsor ID
- CVL-865-1002
- Conditions
- Healthy
- Keywords
- Healthy Volunteer, Bioavailability, Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Cerevel Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 21 Nov 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, single-center trial in healthy participants. This is a crossover design, open-label treatment trial with 3 periods, 6 sequences.
Detailed description
The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food on Darigabat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a Phase 1, single-center trial in healthy participants. The trial is an open-label, randomized, 3-period, 6-sequence, crossover design to investigate the relative bioavailability and effect of food of Darigabat from a single oral.
| Arm | Type | Receives |
|---|---|---|
| Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fasted (Without Food) | Experimental | Drug: DarigabatOral Dose |
| Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fed (With food) | Experimental | Drug: DarigabatOral Dose |
| Single Oral Dose of 25 mg administered as 2 x 7.5 and 2 x 5.0 mg tablets, Fasted (Without Food) | Experimental | Drug: DarigabatOral Dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women of nonchildbearing potential and men, ages 18 to 55 years, inclusive.
- Healthy as determined by medical evaluation by the investigator.
- Body mass index of 18.5 to 30.0 kg/m2, inclusive, and a total body weight >50 kg (110 lbs).
- A male participant with a pregnant or a nonpregnant partner of childbearing potential must agree to use contraception.
- Capable of giving signed informed consent and complying with study requirements.
Key exclusion criteria (13 listed)
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease.
- Serious risk of suicide in the opinion of the investigator.
- History of substance or alcohol-use disorder (excluding nicotine or caffeine) within 12 months prior to signing the ICF.
- Any condition that could possibly affect drug absorption.
- Receipt of SARS-CoV2 vaccine or booster as follows:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarigabatTablets | Drug | Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fasted (Without Food), Single Oral Dose of 25 mg administered as 1 x 25 mg tablet, Fed (With food), Single Oral Dose of 25 mg administered as 2 x 7.5 and 2 x 5.0 mg tablets, Fasted (Without Food) |
Primary outcome
Single Dose: Peak Plasma Concentrations
Time frame: Day 1 to Day 4
Peak Plasma Concentration (Cmax) for Darigabat under fasted conditions
Single Dose: Area under the plasma concentration-time curve
Time frame: Day 1 to Day 4
Area under the plasma concentration-time curve (AUC) for Darigabat under fasted conditions
Single Dose: Area under the plasma concentration-time curve from time zero to last concentration measured
Time frame: Day 1 to Day 4
Area under the plasma concentration-time curve from time zero to last concentration measured (AUClast) for Darigabat under fasted conditions
Single Dose: Time of Maximum Observed Plasma Concentrations
Time frame: Day 1 to Day 4
Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted conditions
Secondary Objective: Single Dose: Peak Plasma Concentrations
Time frame: Day 1 to Day 4
Peak Plasma Concentration (Cmax) for Darigabat under fed and fasted conditions
Secondary Objective: Single Dose: Area under the plasma concentration-time curve
Time frame: Day 1 to Day 4
Area under the plasma concentration-time curve (AUC) for Darigabat under fed and fasted conditions
Secondary Objective: Single Dose: Area under the plasma concentration-time curve from time zero to infinity
Time frame: Day 1 to Day 4
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for CVL-865 under fed and fasted conditions
Secondary Objective: Single Dose: Time of Maximum Observed Plasma Concentrations
Time frame: Day 1 to Day 4
Time of Maximum Observed Plasma Concentrations (Tmax) for Darigabat under fasted and fed conditions
6 secondary outcomes
Secondary Outcome (AE)
Time frame: Day 1 to Day 4
Secondary Outcome (ECGs)
Time frame: Day 1 to Day 4
Secondary Outcome (Labs)
Time frame: Day 1 to Day 4
Secondary Outcome (Vital Signs)
Time frame: Day 1 to Day 4
Secondary Outcome (Physical/Neurological Exam)
Time frame: Day 1 to Day 4
Secondary Outcome (C-SSRS)
Time frame: Day 1 to Day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann M Dandurand, MD study director
Cerevel Therapeutics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Darigabat in people with Healthy, 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 5 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 21 Jan 2022. 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?
Single Dose: Peak Plasma Concentrations (time frame: Day 1 to Day 4). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2022.