Trial · NCT02224664
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline (Day 1) up to Day 30 | Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. | participants | NUMBER |
| PRIMARY | Number of Participants With Laboratory Test Abnormalities | Baseline up to Day 30 | Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | participants | NUMBER |
| PRIMARY | Number of Participants With Vital Sign Abnormalities | Baseline up to Day 30 | Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, 'n' signifies the number of participants evaluable for the specific category. | participants | NUMBER |
| PRIMARY | Number of Participants With Electrocardiogram (ECG) Abnormalities | Baseline up to Day 30 | Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings | Baseline up to Day 30 | Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. | participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Significant Neurological Examination Abnormality | Baseline up to Day 30 | Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 1 and/or Period 2. | participants | NUMBER |
| PRIMARY | Number of Participants With Categorical Scores on The Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline up to Day 30 | Safety analysis set included all participants who received at least 1 dose of study medication (L-Dopa or PF-06649751) in Period 2. This outcome measure was not planned to be assessed in lead-in period (L-dopa). | participants | NUMBER |
| PRIMARY | Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13 | Baseline, Day 13 | Safety analysis set included all participants who received at least 1 dose of study medication(L-Dopa or PF-06649751) in Period 2. Here,'n' signifies those participants who were evaluable at specified time points for each reporting arm.This outcome measure was not planned to be assessed in lead-in period (L-dopa). | hour | MEAN |
| PRIMARY | Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 20 | Baseline, Day 20 | Safety analysis set included all participants who received at least 1 dose of study medication(L-Dopa or PF-06649751) in Period 2. Here,'n' signifies those participants who were evaluable at specified time points for each reporting arm. This outcome measure was not planned to be assessed in lead-in period (L-dopa). | hour | MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of L-Dopa | Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1 | The L-Dopa pharmacokinetic (PK) parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) of L-Dopa | Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1 | The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. | hour | MEDIAN |
| SECONDARY | Apparent Clearance (CL/F) of L-Dopa | Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1 | The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. | liter per hour (L/hr) | GEOMETRIC_MEAN |
| SECONDARY | Terminal Half-Life (t1/2) of L-Dopa | Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1 | The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | hour | MEAN |
| SECONDARY | Area Under the Curve From Time Zero Extrapolated to Infinite Time of L-Dopa | Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1 | The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | nanogram*hour per milliliter (ng*hr/mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time Zero to Last Quantifiable Concentration of L-Dopa | Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1 | The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. | ng*hr/mL | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution (Vz/F) of L-Dopa | Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1 | The L-Dopa PK parameter analysis set included all participants who received at least 1 dose of L-Dopa in open label Period 1 with at least 1 of the PK parameters of interest. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome measure. | Liter (L) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of PF-06649751 | Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22 | The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, 'n' signifies those participants who were evaluable at specified time points for each reporting arm, respectively. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06649751 | Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22 | The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, 'n' signifies those participants who were evaluable at specified time point for each reprting arm, respectively. | hour | MEDIAN |
| SECONDARY | Apparent Clearance (CL/F) of PF-06649751 | Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 22 | The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure. | L/hr | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time Zero to End of Dosing Interval of PF-06649751 | Pre-dose on Day 3, 4, 8, 11, 14, 17, 20, Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 7, 13, 22 | The PF-06649751 PK parameter analysis set included all participants treated and who had at least 1 of the PK parameters of interest in at least 1 treatment period during period 2. Here, 'n' signifies those participants who were evaluable at specified time point for each reporting arm, respectively. | ng*hr/mL | GEOMETRIC_MEAN |
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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