Trial · NCT02224664
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson's Disease
NCT02224664, Phase 1, Completed, Pfizer; results first posted 2017-03-27
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson's Disease. Trials, record NCT02224664. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02224664
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson's Disease
- NCT number
- NCT02224664
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 50 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Parkinson's Disease
- Interventions
- PF-06649751, PF-06649751, PF-06649751, PF-06649751
- First posted
- 2014-08-25
- Last updated
- 2017-03-27
- Other registries' IDs
- eudract:2014-003472-22
- Results first posted
- 2017-03-27
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline (Day 1) up to Day 30 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug to the end of study (up to Day 30) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events. |
| Primary | Number of Participants With Laboratory Test Abnormalities | Baseline up to Day 30 | Criteria for laboratory abnormalities: Hemoglobin (Hgb),hematocrit, red blood cell(RBC) count: less than(\<)0.8\*lower limit of normal(LLN),mean corpuscular Hgb, mean corpuscular volume, mean corpuscular Hgb concentration:\<0.9\*LLN, greater than (\>)1.1\*upper limit of normal(ULN),platelet:\<0.5\*LLN,\>1.75\*ULN,lymphocyte,neutrophil:\<0.8\*LLN, \>1.2\*ULN, basophil, eosinophil, monocyte:\>1.2\*ULN, WBC:\<0.6\*LLN, \>1.5\*ULN;total bilirubin\>1.5\*ULN, aspartate aminotransferase,alanine aminotransferase,alkaline phosphatase:\>3.0\*ULN,total protein,albumin:\<0.8\*LLN,\>1.2\*ULN;blood urea nitrogen,creatinine:\>1.3\*ULN, uric acid\>1.2\*ULN;sodium\<0.95\*LLN,\>1.05\*ULN,potassium,chloride,calcium,bicarbonate:\<0.9\*LLN,\>1.1\*ULN;glucose\<0.6\*LLN,\>1.5\*ULN,urine pH:\<4.5, \>8; urine: WBC, RBC greater than or equal to (\>=)20/high performance field, bacteria: \>20; urobilinogen, urine: glucose, ketone, protein, Hgb, nitrite, leukocyte esterase, bilirubin: \>=1. |
| Primary | Number of Participants With Vital Sign Abnormalities | Baseline up to Day 30 | Criteria for vital sign abnormality included supine pulse rate of \<40 beats per minute (bpm) or \>120 bpm, standing pulse rate of \<40 bpm or \>140 bpm, supine and standing systolic blood pressure (SBP) \<90 millimeter of mercury (mmHg), supine and standing diastolic blood pressure (DBP) \<50 mmHg, supine and standing SBP of \>=30 mmHg maximum (max.) increase from baseline (IFB) and and decrease from baseline (DFB) in same posture, supine and Standing DBP of \>=20 mmHg max. increase and decrease from baseline in same posture. Categories in which there was atleast 1 abnormality are reported in this outcome measure. |
| Primary | Number of Participants With Electrocardiogram (ECG) Abnormalities | Baseline up to Day 30 | Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 msec and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, maximum QRS interval \>=140 msec and a maximum IFB: Pctchg\>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to \<480 msec, 480 msec to \<500 msec or \>=500 msec and a maximum change of \<=30change\<60 or \>=60 msec from baseline. |
| Primary | Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings | Baseline up to Day 30 | Physical examination included examination of the head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision. |
| Primary | Number of Participants With Clinically Significant Neurological Examination Abnormality | Baseline up to Day 30 | The complete or full neurological examination included assessment of the cranial nerves; muscle strength, tone, cortical drift, abnormal movements; deep tendon reflexes; sensory exam, coordination, gait and station. Higher cortical and motor function was considered part of the complete neurological exam. Findings were considered abnormal as confirmed by a certified neurologist. |
| Primary | Number of Participants With Categorical Scores on The Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline up to Day 30 | The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4: any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior"). |
| Primary | Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13 | Baseline, Day 13 | According to Parkinson's disease diaries of participants "OFF" time was a time period when the medication no longer providing benefit with regard to mobility, slowness, and stiffness and participants experienced relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia. "ON" time was a time period when medication was providing benefit with regard to mobility, slowness, and stiffness. "ON" time was classified as associated with or without troublesome dyskinesia (TD) that interfere with activities of daily living and with or without dyskinesia. "OFF" time and "ON" time with TD were generally considered to be "bad time" with regard to motor function, whereas "ON" time without dyskinesia (WD) and with non- troublesome dyskinesia (NTD) were generally considered to be "good time". |
| Primary | Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 20 | Baseline, Day 20 | According to Parkinson's disease diaries of participants "OFF" time was a time period when the medication no longer providing benefit with regard to mobility, slowness, and stiffness and participants experienced relatively poor overall function with worsening of tremor, rigidity, balance, or bradykinesia. "ON" time was a time period when medication was providing benefit with regard to mobility, slowness, and stiffness. "ON" time was classified as associated with or without troublesome dyskinesia (TD) that interfere with activities of daily living and with or without dyskinesia. "OFF" time and "ON" time with TD were generally considered to be "bad time" with regard to motor function, whereas "ON" time without dyskinesia (WD) and with non- troublesome dyskinesia (NTD) were generally considered to be "good time". |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of L-Dopa | Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group244
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | L-Dopa | AEs | 9 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-06649751 5 mg + L-Dopa | AEs | 9 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-06649751 15 mg + L-Dopa | AEs | 7 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID) | AEs | 5 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-06649751 25 mg + L-Dopa | AEs | 15 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | L-Dopa | SAEs | 0 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-06649751 5 mg + L-Dopa | SAEs | 0 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-06649751 15 mg + L-Dopa | SAEs | 0 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID) | SAEs | 0 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | PF-06649751 25 mg + L-Dopa | SAEs | 1 | participants |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Lead-in Period (3 Days) | STARTED | L-Dopa | 50 | |
| Lead-in Period (3 Days) | STARTED | PF-06649751 5 mg + L-Dopa | 0 | |
| Lead-in Period (3 Days) | STARTED | PF-06649751 15 mg + L-Dopa | 0 | |
| Lead-in Period (3 Days) | STARTED | PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID) | 0 | |
| Lead-in Period (3 Days) | STARTED | PF-06649751 25 mg + L-Dopa | 0 | |
| Lead-in Period (3 Days) | COMPLETED | L-Dopa | 45 | |
| Lead-in Period (3 Days) | COMPLETED | PF-06649751 5 mg + L-Dopa | 0 | |
| Lead-in Period (3 Days) | COMPLETED | PF-06649751 15 mg + L-Dopa | 0 | |
| Lead-in Period (3 Days) | COMPLETED | PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID) | 0 | |
| Lead-in Period (3 Days) | COMPLETED | PF-06649751 25 mg + L-Dopa | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events335
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | L-Dopa | 0 | 50 | |
| other | Palpitations | Cardiac disorders | PF-06649751 5 mg + L-Dopa | 1 | 9 | |
| other | Palpitations | Cardiac disorders | PF-06649751 15 mg + L-Dopa | 0 | 11 | |
| other | Palpitations | Cardiac disorders | PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID) | 0 | 6 | |
| other | Palpitations | Cardiac disorders | PF-06649751 25 mg + L-Dopa | 0 | 19 | |
| other | Tinnitus | Ear and labyrinth disorders | L-Dopa | 0 | 50 | |
| other | Tinnitus | Ear and labyrinth disorders | PF-06649751 5 mg + L-Dopa | 0 | 9 | |
| other | Tinnitus | Ear and labyrinth disorders | PF-06649751 15 mg + L-Dopa | 0 | 11 | |
| other | Tinnitus | Ear and labyrinth disorders | PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID) | 1 | 6 | |
| other | Tinnitus | Ear and labyrinth disorders | PF-06649751 25 mg + L-Dopa | 0 | 19 |
1 to 10 of 335Source ClinicalTrials.gov
See all 335 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | L-Dopa | ||
| Total, all-cause mortality | PF-06649751 5 mg + L-Dopa | ||
| Total, all-cause mortality | PF-06649751 15 mg + L-Dopa | ||
| Total, all-cause mortality | PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID) | ||
| Total, all-cause mortality | PF-06649751 25 mg + L-Dopa | ||
| Total, other adverse events | L-Dopa | 8 | 50 |
| Total, other adverse events | PF-06649751 5 mg + L-Dopa | 9 | 9 |
| Total, other adverse events | PF-06649751 15 mg + L-Dopa | 7 | 11 |
| Total, other adverse events | PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID) | 5 | 6 |
| Total, other adverse events | PF-06649751 25 mg + L-Dopa | 15 | 19 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30361858 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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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