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Trial · NCT04295642

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySingle Dose: Peak Plasma ConcentrationDay 1 to 12Peak Plasma Concentration (Cmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
PrimarySingle Dose:Area under the plasma concentration-time curveDay 1 to 12Area under the plasma concentration-time curve (AUC) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
PrimarySingle Dose: Area under the plasma concentration-time curve from time zero to infinityDay 1 to 12Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
PrimarySingle Dose: Time to Maximum ConcentrationDay 1 to 12Time to Maximum Concentration (Tmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
PrimaryMultiple Dose: Peak Plasma ConcentrationDay 16 to 29Peak Plasma Concentration (Cmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
PrimaryMultiple Dose: Area under the plasma concentration-time curveDay 16 to 29Area under the plasma concentration-time curve (AUCτ) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
PrimaryMultiple Dose: Time to Maximum ConcentrationDay 16 to 29Time to Maximum Concentration (Tmax) for CVL-751 and its metabolite (PF-06752844) under fasted and fed conditions
SecondarySecondary Outcome (AE) Number of subjects with reported Treatment Emergent Adverse Events (TEAEs)up to Day 35Number of subjects with reported Treatment Emergent Adverse Events (TEAEs)
SecondarySecondary Outcome (Labs) Number of subjects with clinically significant changes in laboratory measuresup to Day 35Number of subjects with clinically significant changes in laboratory measures
SecondarySecondary Outcome (ECGs)Number of subjects with Clinically significant changes in Electrocardiogramup to Day 35Number of subjects with Clinically significant changes in Electrocardiogram measures (PR,RR,QT and QTcF)
SecondarySecondary Outcome (Vital Signs) Number of subjects with Clinically meaningful changes in Vital signsup to Day 35Number of subjects with Clinically meaningful changes in Vital signs
SecondarySecondary Outcome (C-SSRS) - Change from baseline of the Columbia-Suicide Severity Rating Scale(C-SSRS)up to Day 35
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).

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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