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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3DA052166-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This is a 2-part, double-blind, randomized, placebo-controlled, first-in-human trial evaluating a single ascending dose (4-way crossover, Part A) and multiple ascending doses (Part B) of CVL-354.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Cohort 1: Sequence 1 | Experimental | Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 1.5 milligrams (mg) on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 & followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
|
| Part A: Cohort 1: Sequence 2 | Experimental | Participants were randomized to sequence 2 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 & followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
|
| Part A: Cohort 1: Sequence 3 | Experimental | Participants were randomized to sequence 3 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by placebo on Day 1 of Period 3 & followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
|
| Part A: Cohort 1: Sequence 4 | Experimental | Participants were randomized to sequence 4 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 & followed by placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVL-354 | Drug | Oral solution/suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A serious adverse event (SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs. | From the first dose of study drug up to end of follow-up period (Up to 72 days) |
| Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported. | From the first dose of study drug up to end of treatment (Up to 72 days) |
| Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Sign Measurements | Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported. | From the first dose of study drug up to end of treatment (Up to 72 days) |
| Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters |
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Inclusion Criteria:
Exclusion Criteria:
Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine, hematological, immunological, or 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.
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 informed consent form (ICF).
Any condition that could possibly affect drug absorption
Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccination or booster as follows:
Have recently been diagnosed with symptomatic corona virus disease-2019 (COVID-19) or test positive for COVID-19 within 30 days prior to signing the ICF.
Use of prohibited medication prior to randomization or likely to require prohibited concomitant therapy (eg, prescription and over-the-counter medications, herbal medications, vitamins, and supplements) during the trial
Either of the following:
Positive drug screen (including nicotine) or a positive test for alcohol
Abnormal clinical laboratory test results or vital measurements at Screening and Check-in
Estimated glomerular filtration rate at Screening <90 millilitre/minute/1.73m^2 (mL/min/1.73 m^2), as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
Abnormal 12-lead ECG at Screening or initial Check-In (Day -1).
Known allergy or hypersensitivity to the IMP, closely related compounds, or any of their specified ingredients.
Current enrollment or past participation within 30 days or 5 half-lives (whichever is longer) prior to signing the ICF in any other clinical trial involving an IMP.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Leoni, MD, MBA | Cerevel Therapeutics, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Drug Development | Dallas | Texas | 75247 | United States |
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Healthy participants were enrolled in single ascending dose (Part A: Cohorts 1 & 2), food effect (Part A: Cohorts 3) & multiple ascending dose (Part B: Cohorts 1-5) of the study. The data for the 4 sequences in Cohorts 1 and 2 was collected and presented in a pooled manner in the participant flow.
73 participants took part in the study at 1 investigative site in the United States of America from 18 October 2021 to 23 January 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Cohort 1: Sequence 1 | Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 1.5 milligrams (mg) on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 & followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| FG001 | Part A: Cohort 1: Sequence 2 | Participants were randomized to sequence 2 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 & followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| FG002 | Part A: Cohort 1: Sequence 3 | Participants were randomized to sequence 3 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by placebo on Day 1 of Period 3 & followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| FG003 | Part A: Cohort 1: Sequence 4 | Participants were randomized to sequence 4 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 & followed by placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| FG004 | Part A: Cohort 2: Sequence 1 | Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 & followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| FG005 | Part A: Cohort 2: Sequence 2 | Participants were randomized to sequence 2 to receive CVL-354 45 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 & followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| FG006 | Part A: Cohort 2: Sequence 3 | Participants were randomized to sequence 3 to receive CVL-354 45 mg on Day 1 of Period 1 followed by CVL-354 on 90 mg Day 1 of Period 2, followed by placebo on Day 1 of Period 3 & followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| FG007 | Part A: Cohort 2: Sequence 4 | Participants were randomized to sequence 4 to receive CVL- 354 45 mg on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 & placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| FG008 | Part A: Cohort 3: Fed/Fasted Sequence | Participants first received a single oral dose of CVL-354 50 mg, under fed state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fasted state on Day 1 of Period 2, with a washout period of 2 days between both periods. |
| FG009 | Part A: Cohort 3: Fasted/Fed Sequence | Participants first received a single oral dose of CVL-354 50 mg, under fasted state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fed state on Day 1 of Period 2, with a washout period of 2 days between both periods. |
| FG010 | Part B: Pooled Placebo | Participants received oral dose of placebo matching CVL-354, once daily (QD) from Day 1 up to Day 14 of Cohort 1 to 5 in Part B. |
| FG011 | Part B: Cohort 1: CVL-354 10 mg | Participants received oral dose of CVL-354 10 mg, QD from Day 1 up to Day 14 in Cohort 1. |
| FG012 | Part B: Cohort 2: CVL-354 25 mg | Participants received oral dose of CVL-354 25 mg, QD from Day 1 up to Day 14 in Cohort 2. |
| FG013 | Part B: Cohort 3: CVL-354 50 mg | Participants received oral dose of CVL-354 50 mg, QD from Day 1 up to Day 14 in Cohort 3. |
| FG014 | Part B: Cohort 4: CVL-354 80 mg | Participants received oral dose of CVL-354 80 mg, QD from Day 1 up to Day 14 in Cohort 4. |
| FG015 | Part B: Cohort 5: CVL-354 85 mg | Participants received oral dose of CVL-354 85 mg, QD from Day 1 up to Day 14 in Cohort 5. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single Ascending Dose (Up to 13 Weeks) |
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| Multiple Ascending Dose (Up to 12 Weeks) |
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Randomized Population included all participants who were randomized to investigational medicinal product (IMP).
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Cohort 1: Sequence 1 | Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 & followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A: Cohorts 1 and 2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A serious adverse event (SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of follow-up period (Up to 72 days) |
|
Part A: Cohorts 1 and 2: From the first dose of study drug up to end of follow up period (Up to 72 days); Part A: Cohort 3: From the first dose of study drug up to end of follow up period (Up to 22 days); Part B: From the first dose of study drug up to end of follow up period (Up to 31 days)
Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Cohorts 1 and 2: Pooled Placebo | Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cerevel Central Contact | Cerevel Therapeutics | 8572500977 | info@cerevel.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 25, 2022 | Jun 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2023 | Jun 6, 2024 | SAP_001.pdf |
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|
| Part A: Cohort 2: Sequence 1 | Experimental | Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 & followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
|
| Part A: Cohort 2: Sequence 2 | Experimental | Participants were randomized to sequence 2 to receive CVL-354 45 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 & followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
|
| Part A: Cohort 2: Sequence 3 | Experimental | Participants were randomized to sequence 3 to receive CVL-354 45 mg on Day 1 of Period 1 followed by CVL-354 on 90 mg Day 1 of Period 2, followed by placebo on Day 1 of Period 3 & followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
|
| Part A: Cohort 2: Sequence 4 | Experimental | Participants were randomized to sequence 4 to receive CVL-354 45 mg on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 & placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
|
| Part A: Cohort 3: Sequence 1: Fed/Fasted Sequence | Experimental | Participants first received a single oral dose of CVL-354 50 mg, under fed state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fasted state on Day 1 of Period 2, with a washout period of 2 days between both periods. |
|
| Part A: Cohort 3: Sequence 2: Fasted/Fed Sequence | Experimental | Participants first received a single oral dose of CVL-354 50 mg, under fasted state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fed state on Day 1 of Period 2, with a washout period of 2 days between both periods |
|
| Part B: Cohort 1: CVL-354 10 mg | Experimental | Participants received oral dose of CVL-354 10 mg or Placebo, once daily (QD) from Day 1 up to Day 14 in Cohort 1. |
|
| Part B: Cohort 2: CVL-354 25 mg | Experimental | Participants received oral dose of CVL-354 25 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 2. |
|
| Part B: Cohort 3: CVL-354 50 mg | Experimental | Participants received oral dose of CVL-354 50 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 3. |
|
| Part B: Cohort 4: CVL-354 80 mg | Experimental | Participants received oral dose of CVL-354 80 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 4. |
|
| Part B: Cohort 5: CVL-354 85 mg | Experimental | Participants received oral dose of CVL-354 85 mg or Placebo, QD from Day 1 up to Day 14 in Cohort 5. |
|
| Placebo | Drug | Placebo matched to CVL-354 |
|
| CVL-354 | Drug | Capsule |
|
Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported. |
| From the first dose of study drug up to end of treatment (Up to 72 days) |
| Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations | The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported. | From the first dose of study drug up to end of treatment (Up to 72 days) |
| Part A: Cohorts 1 and 2: Number of Participants With Changes in Suicidal Ideation or Suicidal Behavior Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS) | The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior. Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category. | From the first dose of study drug up to end of treatment (Up to 72 days) |
| Part A: Cohort 3: Number of Participants With TEAEs | An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A SAE was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs. | From the first dose of study drug up to end of follow up period (Up to 22 days) |
| Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in ECG Parameters | ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported. | From the first dose of study drug up to end of treatment (Up to 22 days) |
| Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Vital Sign Measurements | Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported. | From the first dose of study drug up to end of treatment (Up to 22 days) |
| Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported. | From the first dose of study drug up to end of treatment (Up to 22 days) |
| Part A: Cohort 3: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations | The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported. | From the first dose of study drug up to end of treatment (Up to 22 days) |
| Part A: Cohort 3: Number of Participants With Changes in C-SSRS | The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior. Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category. | From the first dose of study drug up to end of treatment (Up to 22 days) |
| Part B: Number of Participants With TEAEs | An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A SAE was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs. | From the first dose of study drug up to end of follow up period (Up to 31 days) |
| Part B: Number of Participants With Clinically Significant Changes in ECG Parameters | ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported. | From the first dose of study drug up to end of treatment (Up to 31 days) |
| Part B: Number of Participants With Clinically Significant Changes in Vital Sign Measurements | Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported. | From the first dose of study drug up to end of treatment (Up to 31 days) |
| Part B: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported. | From the first dose of study drug up to end of treatment (Up to 31 days) |
| Part B: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations | The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported. | From the first dose of study drug up to end of treatment (Up to 31 days) |
| Part B: Number of Participants With Changes in C-SSRS | The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category. | From the first dose of study drug up to end of treatment (Up to 31 days) |
| Investigator's Discretion |
|
| Withdrawal of Consent |
|
| Other |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part A: Cohort 1: Sequence 2 |
Participants were randomized to sequence 2 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 & followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| BG002 | Part A: Cohort 1: Sequence 3 | Participants were randomized to sequence 3 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by placebo on Day 1 of Period 3 & followed by CVL-354 15 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| BG003 | Part A: Cohort 1: Sequence 4 | Participants were randomized to sequence 4 to receive CVL-354 0.5 mg on Day 1 of Period 1 followed by CVL-354 1.5 mg on Day 1 of Period 2, followed by CVL-354 5 mg on Day 1 of Period 3 & followed by placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| BG004 | Part A: Cohort 2: Sequence 1 | Participants were randomized to sequence 1 to receive placebo on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 & followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| BG005 | Part A: Cohort 2: Sequence 2 | Participants were randomized to sequence 2 to receive CVL-354 45 mg on Day 1 of Period 1 followed by placebo on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 & followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| BG006 | Part A: Cohort 2: Sequence 3 | Participants were randomized to sequence 3 to receive CVL-354 45 mg on Day 1 of Period 1 followed by CVL-354 on 90 mg Day 1 of Period 2, followed by placebo on Day 1 of Period 3 & followed by CVL-354 200 mg on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| BG007 | Part A: Cohort 2: Sequence 4 | Participants were randomized to sequence 4 to receive CVL- 354 45 mg on Day 1 of Period 1 followed by CVL-354 90 mg on Day 1 of Period 2, followed by CVL-354 150 mg on Day 1 of Period 3 & placebo on Day 1 of Period 4. Each dosing period was separated by a washout period of at least 5 days. |
| BG008 | Part A: Cohort 3: Fed/Fasted Sequence | Participants first received a single oral dose of CVL-354 50 mg, under fed state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fasted state on Day 1 of Period 2, with a washout period of 2 days between both periods. |
| BG009 | Part A: Cohort 3: Fasted/Fed Sequence | Participants first received a single oral dose of CVL-354 50 mg, under fasted state on Day 1 of Period 1 followed by a single oral dose of CVL-354 50 mg under fed state on Day 1 of Period 2, with a washout period of 2 days between both periods. |
| BG010 | Part B: Pooled Placebo | Participants received oral dose of placebo matching CVL-354, QD from Day 1 up to Day 14 of Cohort 1 to 5 in Part B. |
| BG011 | Part B: Cohort 1: CVL-354 10 mg | Participants received oral dose of CVL-354 10 mg, QD from Day 1 up to Day 14 in Cohort 1. |
| BG012 | Part B: Cohort 2: CVL-354 25 mg | Participants received oral dose of CVL-354 25 mg, QD from Day 1 up to Day 14 in Cohort 2. |
| BG013 | Part B: Cohort 3: CVL-354 50 mg | Participants received oral dose of CVL-354 50 mg, QD from Day 1 up to Day 14 in Cohort 3. |
| BG014 | Part B: Cohort 4: CVL-354 80 mg | Participants received oral dose of CVL-354 80 mg, QD from Day 1 up to Day 14 in Cohort 4. |
| BG015 | Part B: Cohort 5: CVL-354 85 mg | Participants received oral dose of CVL-354 85 mg, QD from Day 1 up to Day 14 in Cohort 5. |
| BG016 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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Participants received a single oral dose of placebo matching CVL-354 on Day 1 of either of the 4 periods in Cohorts 1 and 2 of Part A. |
| OG001 | Part A: Cohort 1: CVL-354 0.5 mg | Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods. |
| OG002 | Part A: Cohort 1: CVL-354 1.5 mg | Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods. |
| OG003 | Part A: Cohort 1: CVL-354 5 mg | Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods. |
| OG004 | Part A: Cohort 1: CVL-354 15 mg | Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods. |
| OG005 | Part A: Cohort 2: CVL-354 45 mg | Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods. |
| OG006 | Part A: Cohort 2: CVL-354 90 mg | Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods. |
| OG007 | Part A: Cohort 2: CVL-354 150 mg | Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods. |
| OG008 | Part A: Cohort 2: CVL-354 200 mg | Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods. |
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| Primary | Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 72 days) |
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| Primary | Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Vital Sign Measurements | Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 72 days) |
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| Primary | Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 72 days) |
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| Primary | Part A: Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations | The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 72 days) |
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| Primary | Part A: Cohorts 1 and 2: Number of Participants With Changes in Suicidal Ideation or Suicidal Behavior Assessed Using the Columbia Suicide-Severity Rating Scale (C-SSRS) | The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior. Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 72 days) |
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| Primary | Part A: Cohort 3: Number of Participants With TEAEs | An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A SAE was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of follow up period (Up to 22 days) |
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| Primary | Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in ECG Parameters | ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 22 days) |
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| Primary | Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Vital Sign Measurements | Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 22 days) |
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| Primary | Part A: Cohorts 3: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 22 days) |
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| Primary | Part A: Cohort 3: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations | The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 22 days) |
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| Primary | Part A: Cohort 3: Number of Participants With Changes in C-SSRS | The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior. Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 22 days) |
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| Primary | Part B: Number of Participants With TEAEs | An AE was any untoward medical occurrence in a clinical trial participant, temporally associated with the use of trial treatment, whether or not considered related to the trial treatment. A SAE was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Adverse event which was reported to have started on Day 1 with no associated onset time were defined as TEAEs. TEAEs included both serious and non-serious TEAEs. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of follow up period (Up to 31 days) |
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|
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| Primary | Part B: Number of Participants With Clinically Significant Changes in ECG Parameters | ECG parameters were assessed using continuous ECG recordings and standard 12-lead ECGs. The parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals, PR intervals, corrected QT (QTc) intervals, corrected QT with Bazett formula (QTcB), and corrected QT with Fredericia (QTcF) parameters measurement. Clinical significance of changes in ECG parameters was based on investigator's interpretation. Number of participants with clinically significant changes in ECG were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 31 days) |
|
|
|
| Primary | Part B: Number of Participants With Clinically Significant Changes in Vital Sign Measurements | Vital signs include systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature. Clinical significance of changes in vital signs measurements was based on investigator's interpretation. Number of participants with clinically significant changes in vital signs were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 31 days) |
|
|
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| Primary | Part B: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | Laboratory parameters included blood chemistry, hematology, and urinalysis. Clinical significance of changes in laboratory parameters was based on investigator's interpretation. Number of participants with clinically significant changes in laboratory parameters (included hematology, blood chemistry, and urinalysis) were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 31 days) |
|
|
|
| Primary | Part B: Number of Participants With Clinically Significant Changes in Physical and Neurological Examinations | The full physical examination included a review of the following body systems: head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, and musculoskeletal systems. The full neurological examination included an assessment of the participant's mental status (level of consciousness, orientation, speech, memory, etc), cranial nerves, motor (muscle appearance, tone, strength and reflexes), sensation (including Romberg sign), coordination, and gait. Clinical significance in changes of physical and neurological examination results were based on investigator's interpretation. Number of participants with clinically significant changes in physical and neurological examinations were reported. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 31 days) |
|
|
|
| Primary | Part B: Number of Participants With Changes in C-SSRS | The C-SSRS is comprised of 10 categories with binary responses. The 10 categories include: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide. Categories 1-5 represent Suicidal Ideation and categories 6-10 represent Suicidal Behavior Each category is scored as 1 if there is a positive response in the category and a 0 if there are no positive responses in the category. | Safety Analysis Set included all randomized participants who had received at least 1 dose of IMP. | Posted | Count of Participants | Participants | From the first dose of study drug up to end of treatment (Up to 31 days) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Part A: Cohort 1: CVL-354 0.5 mg | Participants received a single oral dose of CVL-354 0.5 mg on Day 1 of either of the 4 periods. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Part A: Cohort 1: CVL-354 1.5 mg | Participants received a single oral dose of CVL-354 1.5 mg on Day 1 of either of the 4 periods. | 0 | 6 | 0 | 6 | 0 | 6 |
| EG003 | Part A: Cohort 1: CVL-354 5 mg | Participants received a single oral dose of CVL-354 5 mg on Day 1 of either of the 4 periods. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG004 | Part A: Cohort 1: CVL-354 15 mg | Participants received a single oral dose of CVL-354 15 mg on Day 1 of either of the 4 periods. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG005 | Part A: Cohort 2: CVL-354 45 mg | Participants received a single oral dose of CVL-354 45 mg on Day 1 of either of the 4 periods. | 0 | 5 | 0 | 5 | 1 | 5 |
| EG006 | Part A: Cohort 2: CVL-354 90 mg | Participants received a single oral dose of CVL-354 90 mg on Day 1 of either of the 4 periods. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG007 | Part A: Cohort 2: CVL-354 150 mg | Participants received a single oral dose of CVL-354 150 mg on Day 1 of either of the 4 periods. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG008 | Part A: Cohort 2: CVL-354 200 mg | Participants received a single oral dose of CVL-354 200 mg on Day 1 of either of the 4 periods. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG009 | Part A: Cohort 3: Fed State | Participants received a single oral dose of CVL-354 50 mg under fed state on Day 1 of either Period 1 or Period 2. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG010 | Part A: Cohort 3: Fasted State | Participants received a single oral dose of CVL-354 50 mg under fasted state on Day 1 of either Period 1 or Period 2. | 0 | 7 | 0 | 7 | 2 | 7 |
| EG011 | Part B: Pooled Placebo | Participants received oral dose of placebo matching CVL-354, QD from Day 1 up to Day 14 of Cohort 1 to 5 in Part B. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG012 | Part B: Cohort 1: CVL-354 10 mg | Participants received oral dose of CVL-354 10 mg, QD from Day 1 up to Day 14 in Cohort 1. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG013 | Part B: Cohort 2: CVL-354 25 mg | Participants received oral dose of CVL-354 25 mg, QD from Day 1 up to Day 14 in Cohort 2. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG014 | Part B: Cohort 3: CVL-354 50 mg | Participants received oral dose of CVL-354 50 mg, QD from Day 1 up to Day 14 in Cohort 3. | 0 | 7 | 0 | 7 | 2 | 7 |
| EG015 | Part B: Cohort 4: CVL-354 80 mg | Participants received oral doses of CVL-354 80 mg, QD from Day 1 up to Day 14 in Cohort 4. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG016 | Part B: Cohort 5: CVL-354 85 mg | Participants received oral doses of CVL-354 85 mg, QD from Day 1 up to Day 14 in Cohort 5. | 0 | 8 | 0 | 8 | 3 | 8 |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Coronavirus disease 2019 (COVID-19) | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Product taste abnormal | Product Issues | MedDRA 25.1 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Laryngitis viral | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Urethritis chlamydial | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
Not provided