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Outcome Measures

Primary Outcomes (8)

Number of Subjects with reported Treatment Emergent Adverse Events (TEAEs)
At the end of Period 3 (30 Days)
Number of Subjects with Clinically significant changes in Electrocardiogram measures (PR, RR, QT and QTcF)
At the end of Period 3 (30 Days)
Number of Subjects with Clinically meaningful changes in Vital signs (Systolic and Diastolic blood pressures, heart rate, respiratory rate and body temperature)
At the end of Period 3 (30 Days)
Number of Subjects with Clinically significant changes in laboratory measures
Number of subjects with clinically significant changes in hematology, serum chemistry and urinalysis will be reported
At the end of Period 3 (30 Days)
Change 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).
At the end of Period 3 (30 Days)
Change from Baseline of Simpson-Angus Scale (SAS) Results
Evaluating Extrapyramidal symptoms using the SAS. The SAS consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items.
At the end of Period 3 (30 Days)
Change from Baseline of Abnormal Involuntary Movement Scale (AIMS) Results
The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) are observed unobtrusively while the subject is at rest, and the investigator also makes global judgments on the subject's dyskinesias (items 8 through 10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the subject's dental status. The AIMS Movement Rating Score is defined as the sum of items 1 through 7 (ie, items 1 through 4, facial and oral movements; items 5 and 6, extremity movements; and item 7, trunk movements).
At the end of Period 3 (30 Days)
Change from Baseline of Barnes Akathisia Rating Scale (BARS) Results
Evaluating Extrapyramidal symptoms using the BARS. The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the subject, subjective distress due to akathisia, and global clinical assessment of akathisia. The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with a score of 0 representing absence of symptom and a score of 5 representing severe akathisia.
At the end of Period 3 (30 Days)

Study Arms (14)

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

ACTIVE COMPARATOR

Oral suspension/solution

Drug: CVL-936

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

PLACEBO COMPARATOR

Matching Placebo; Oral suspension/solution

Drug: Matching Placebo

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

ACTIVE COMPARATOR

Oral suspension/solution

Drug: CVL-936

Interventions

CVL-936Drug

CVL-936

Active Comparator: Group 1 Period 1: 0.5mg CVL-936Active Comparator: Group 1 Period 2:TBD mg CVL-936Active Comparator: Group 1 Period 3:TBD mg CVL-936Active Comparator: Group 2 Period 1:TBD mg CVL-936Active Comparator: Group 2 Period 2:TBD mg CVL-936Active Comparator: Group 2 Period 3:TBD mg CVL-936Active Comparator: Group 3: TBD mg CVL-936

Matching Placebo

Study Design

Study Type

interventional

Phase

phase 1

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Purpose

TREATMENT

Intervention Model

SEQUENTIAL

Model Details: 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.

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (8)

Study Arms (14)

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

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

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

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

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

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

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

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

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

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

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

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

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

Active Comparator: Group 3: TBD mg CVL-936

Placebo Comparator: Group 3: TBD mg Matching Placebo

Data Sharing

Source record

Locations