MedDataX Logo

A Single Ascending Dose Trial of CVL-936 in Healthy Subjects

NCT ID: NCT04232878

Last Updated: 2020-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-16

Study Completion Date

2020-05-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CVL-936 following single ascending oral doses in healthy subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Single and Multiple Ascending Dose Trial of CVL-354 in Healthy Participants

NCT05138653

Healthy Participants
COMPLETED PHASE1

A Study to Assess the Adverse Events and How Oral ABBV-1042 Moves Through the Body of Healthy Adult Participants

NCT07222709

Healthy Volunteer
RECRUITING PHASE1

Single Ascending Dose Study of NRS 033 in Healthy Volunteers

NCT05724797

Healthy Volunteers
COMPLETED PHASE1

A Study to Test the Safety/Tolerability of Increasing Doses of LNP1892 Versus Placebo in Healthy Male/Female Subjects

NCT02174237

Healthy
COMPLETED PHASE1

Increasing Dose Tolerance Study in Healthy Male Volunteers After Administration of BIII 890 CL

NCT02268136

Healthy
TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Substance Use Disorders (SUD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

A sample size of 9 subjects per cohort has been chosen based on the need to minimize exposure of humans to CVL-936 and PF-06815106 and the requirement to provide adequate safety, tolerability, and PK information at each dose. Each cohort will be conducted as a crossover design with 3 periods and each cohort will have up to 6 subjects receiving CVL-936 and 3 subjects receiving placebo within each period, with a total of approximately 18 subjects if 2 cohorts complete or a total of approximately 27 subjects if 3 cohorts complete.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Comparator: Group 1 Period 1: 0.5mg CVL-936

Oral suspension/solution

Group Type ACTIVE_COMPARATOR

CVL-936

Intervention Type DRUG

CVL-936

Placebo Comparator: Group 1 Period 1: 0.5mg Matching Placebo

Matching Placebo; Oral suspension/solution

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Placebo matching CVL-936

Active Comparator: Group 1 Period 2:TBD mg CVL-936

Oral suspension/solution

Group Type ACTIVE_COMPARATOR

CVL-936

Intervention Type DRUG

CVL-936

Placebo Comparator: Group 1 Period 2:TBD mg Matching Placebo

Matching Placebo; Oral suspension/solution

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Placebo matching CVL-936

Active Comparator: Group 1 Period 3:TBD mg CVL-936

Oral suspension/solution

Group Type ACTIVE_COMPARATOR

CVL-936

Intervention Type DRUG

CVL-936

Placebo Comparator: Group 1 Period 3:TBD mg Matching Placebo

Matching Placebo; Oral suspension/solution

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Placebo matching CVL-936

Active Comparator: Group 2 Period 1:TBD mg CVL-936

Oral suspension/solution

Group Type ACTIVE_COMPARATOR

CVL-936

Intervention Type DRUG

CVL-936

Placebo Comparator: Group 2 Period 1:TBD mg Matching Placebo

Matching Placebo; Oral suspension/solution

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Placebo matching CVL-936

Active Comparator: Group 2 Period 2:TBD mg CVL-936

Oral suspension/solution

Group Type ACTIVE_COMPARATOR

CVL-936

Intervention Type DRUG

CVL-936

Placebo Comparator: Group 2 Period 2:TBD mg Matching Placebo

Matching Placebo; Oral suspension/solution

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Placebo matching CVL-936

Active Comparator: Group 2 Period 3:TBD mg CVL-936

Oral suspension/solution

Group Type ACTIVE_COMPARATOR

CVL-936

Intervention Type DRUG

CVL-936

Placebo Comparator: Group 2 Period 3:TBD mg Matching Placebo

Matching Placebo; Oral suspension/solution

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Placebo matching CVL-936

Active Comparator: Group 3: TBD mg CVL-936

Oral suspension/solution

Group Type ACTIVE_COMPARATOR

CVL-936

Intervention Type DRUG

CVL-936

Placebo Comparator: Group 3: TBD mg Matching Placebo

Matching Placebo; Oral suspension/solution

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Placebo matching CVL-936

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CVL-936

CVL-936

Intervention Type DRUG

Matching Placebo

Placebo matching CVL-936

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1\. Healthy male subjects and female subjects of nonchildbearing potential, ages 18 to 50 years

Exclusion Criteria

1. Subjects with a current history of significant pulmonary, gastrointestinal, renal, hepatic, metabolic, endocrine, hematological, immunological, psychiatric, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either subject safety or the results of the trial.
2. Subjects with epilepsy or a history of seizures
3. Systolic supine blood pressure ≥130 mmHg and/or supine diastolic blood pressure ≥80 mmHg at Screening or Day -1, or orthostatic hypotension at Screening or Day -1.
4. Subjects with a history of hypersensitivity to any dopamine-blocker medication.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cerevel Therapeutics, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matt Leoni, MD

Role: STUDY_DIRECTOR

Cerevel Therapeutics, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hassman Research Institute

Marlton, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CVL-936-HV-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A First-in-Human Single and Multiple Ascending Dose Study of MT-201
NCT07219368 RECRUITING PHASE1
First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects
NCT05901883 COMPLETED PHASE1
A Study to Assess NEU-723 in Healthy Participants
NCT05633745 TERMINATED PHASE1
The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers
NCT03926962 COMPLETED PHASE1
Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers
NCT03830463 COMPLETED PHASE1
I.V. Selonabant in Healthy Adult Subjects
NCT07211607 RECRUITING PHASE1
A Study of Sublingually Administered (S)-Ketamine Oral Solution in Healthy Participants
NCT04282746 COMPLETED PHASE1
Study to Determine Tolerability After Intravenous Administration of BIBN 4096 BS in Healthy Male and Female Volunteers
NCT02198352 COMPLETED PHASE1
A Phase 1 Dose Escalation Study of Intravenous VX-993 in Healthy Adults
NCT06394167 COMPLETED PHASE1
A Study of Single Ascending Doses of PF-07258669 in Healthy Adult Participants
NCT04628793 COMPLETED PHASE1
Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult Chinese Participants
NCT07024797 COMPLETED PHASE1
A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy Subjects
NCT01284036 COMPLETED PHASE1
Phase I Study of VLX-1005 in Healthy Subjects
NCT04783545 COMPLETED PHASE1
Evaluating the Safety, Tolerability, Pharmacokinetics, and Effect of Food of Lucid-21-302 in Healthy Volunteers
NCT05821387 COMPLETED PHASE1
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants
NCT03228433 COMPLETED PHASE1
A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Participants
NCT03007693 COMPLETED PHASE1
A Phase 1 Study of S-4321
NCT06877611 RECRUITING PHASE1
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42847922 in Healthy Participants
NCT02230878 COMPLETED PHASE1
Single Ascending Oral Dose Study to Investigate the Effects of OCT461201 in Healthy Volunteers
NCT06398925 COMPLETED PHASE1
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 137882 in Healthy Male Volunteers
NCT01348165 TERMINATED PHASE1
Safety, Tolerability, Pharmacokinetics, and Food Effect of BLU-782 in Healthy Adults
NCT03858075 COMPLETED PHASE1
Single Ascending Dose, Multiple Ascending Dose, Food Effect Study
NCT06938204 COMPLETED PHASE1
A Phase 1 Study of S-1117
NCT06828393 RECRUITING PHASE1
A Single Dose Study to Assess the Safety, Effects, and Blood and Urine Drug Levels of AZD3293 in Healthy Subjects
NCT01739647 COMPLETED PHASE1
A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections
NCT07232004 RECRUITING PHASE1