Trial · NCT02332798
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) (Single Dose) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose) | The pharmacokinetic (PK) concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Cmax (Steady State) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21 | The PK concentration population is defined as all enrolled subjects treated who received at least one dose of PF-04958242 and have at least 1 measureable concentration. | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Time for Cmax (Tmax) (Single Dose) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose) | The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured. | hours | MEDIAN |
| PRIMARY | Tmax (Steady State) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21 | The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured. | hours | MEDIAN |
| PRIMARY | Area Under the Concentration-Time Profile From Time 0 to Time Tau (τ), the Dosing Interval, Where τ = 12 Hours (AUCτ) (Single Dose) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, and 12 hours post-dose) | The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured. | nanograms*hours per milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| PRIMARY | AUCτ (Steady State) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21 | The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured. | ng*h/mL | GEOMETRIC_MEAN |
| PRIMARY | Apparent Oral Clearance (CL/F) (Steady State) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21 | The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured. | milliliter per minute (mL/min) | GEOMETRIC_MEAN |
| PRIMARY | Apparent Volume of Distribution (Vz/F) (Steady State) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21 | The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured. | Liter (L) | GEOMETRIC_MEAN |
| PRIMARY | Terminal Half-Life (t1/2) (Steady State) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21 | The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured. | hours | MEAN |
| PRIMARY | Observed Accumulation Ratio (Rac) (Steady State) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21 | The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured. | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Observed Accumulation Ratio for Cmax (Rac, Cmax) (Steady State) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21 | The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured. | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Peak-to-Trough Ratio at Steady State (PTR) | Day 1 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours post-dose), Day 2, Day 7 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 8, Day 10, Day 14 (0, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12 hours post-dose), Day 15, Day 17, Day 21 | The PK analysis population included all participants enrolled and treated who had at least 1 of the PK parameters interest measured. | Ratio | GEOMETRIC_MEAN |
| PRIMARY | Number of Participants With Abnormal Clinical Laboratory Measurements | Baseline up to Day 21 | The safety analysis population included all participants who received at least 1 dose of the study medication. | participants | NUMBER |
| PRIMARY | Number of Participants With Vital Signs Data Meeting Criteria of Potential Clinical Concern | Baseline up to Day 21 | The safety analysis population included all participants who received at least 1 dose of the study medication. | participants | NUMBER |
| PRIMARY | Number of Participants With Electrocardiogram Data Meeting Criteria of Potential Clinical Concern | Baseline up to Day 21 | The safety analysis population included all participants who received at least 1 dose of the study medication. | participants | NUMBER |
| PRIMARY | Number of Participants With Abnormalities in Neurological Examination | Baseline up to Day 21 | The safety analysis population included all participants who received at least 1 dose of the study medication. | participants | NUMBER |
| PRIMARY | Number of Participants With Abnormalities in Physical Examination | Baseline up to Day 21 | The safety analysis population included all participants who received at least 1 dose of the study medication. | participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to 28 days after last study drug administration | The safety analysis population included all participants who received at least 1 dose of the study medication. | participants | NUMBER |
| PRIMARY | Number of Participants With Positive Response to Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline up to Day 21 | The safety analysis population included all participants who received at least 1 dose of the study medication. | participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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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GET https://conductscience.org/api/trials/v1/NCT02332798/outcomes