Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson's Disease (NCT NCT02224664)
NCT ID: NCT02224664
Last Updated: 2017-03-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Baseline (Day 1) up to Day 30
Results posted on
2017-03-27
Participant Flow
Study consists of 2 periods: Lead-in period (Period 1) and dose escalation period (Period 2). Participants were enrolled in Lead-in period only. Participants completed the lead-in period entered into dose escalation period.
Participant milestones
| Measure |
L-Dopa
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Lead-in Period (3 Days)
STARTED
|
50
|
0
|
0
|
0
|
0
|
|
Lead-in Period (3 Days)
COMPLETED
|
45
|
0
|
0
|
0
|
0
|
|
Lead-in Period (3 Days)
NOT COMPLETED
|
5
|
0
|
0
|
0
|
0
|
|
Dose Escalation Period (21 Days)
STARTED
|
0
|
9
|
11
|
6
|
19
|
|
Dose Escalation Period (21 Days)
COMPLETED
|
0
|
9
|
9
|
3
|
8
|
|
Dose Escalation Period (21 Days)
NOT COMPLETED
|
0
|
0
|
2
|
3
|
11
|
Reasons for withdrawal
| Measure |
L-Dopa
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Lead-in Period (3 Days)
Does not meet entrance criteria
|
5
|
0
|
0
|
0
|
0
|
|
Dose Escalation Period (21 Days)
Adverse Event
|
0
|
0
|
2
|
2
|
7
|
|
Dose Escalation Period (21 Days)
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
4
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Overall Study
n=50 Participants
All participants who received a single oral dose of L-Dopa tablet/capsule (up to a maximum dose of 250 mg, based on investigator's discretion) in lead-in period and/or single oral dose of PF-06649751 tablet (3 mg, 5 mg, 15 mg and 25 mg) in dose escalation period.
|
|---|---|
|
Age, Continuous
|
64.2 years
STANDARD_DEVIATION 6.9 • n=93 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) up to Day 30Population: 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.
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.
Outcome measures
| Measure |
L-Dopa
n=50 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=9 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=6 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
n=19 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
9 participants
|
9 participants
|
7 participants
|
5 participants
|
15 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 30Population: 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.
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.
Outcome measures
| Measure |
L-Dopa
n=49 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=9 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=6 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
n=18 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
17 participants
|
8 participants
|
8 participants
|
5 participants
|
11 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 30Population: 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.
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.
Outcome measures
| Measure |
L-Dopa
n=50 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=9 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=6 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
n=19 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities
Supine SBP: <90 mmHg (n =50, 9, 11, 6, 19)
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Vital Sign Abnormalities
Standing SBP: <90 mmHg (n =50, 9, 11, 6, 19)
|
5 participants
|
2 participants
|
3 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Sign Abnormalities
Supine DBP: <50 mmHg (n =50, 9, 11, 6, 19)
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. IFB in Supine SBP: >=30 mmHg (n=50,9,11,6,19)
|
1 participants
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. IFB in StandingSBP:>=30 mmHg(n= 49,9,11,6,19)
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. IFB in Supine DBP: >=20 mmHg(n= 50,9,11,6,19)
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. IFB in StandingDBP:>=20 mmHg(n= 49,9,11,6,19)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. DFB in Supine SBP:>=30 mmHg (n= 50,9,11,6,19)
|
8 participants
|
1 participants
|
3 participants
|
1 participants
|
5 participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. DFB in StandingSBP:>=30 mmHg(n= 49,9,11,6,19)
|
7 participants
|
2 participants
|
4 participants
|
2 participants
|
4 participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. DFB in Supine DBP:>=20 mmHg (n= 50,9,11,6,19)
|
9 participants
|
3 participants
|
2 participants
|
3 participants
|
8 participants
|
|
Number of Participants With Vital Sign Abnormalities
Max. DFB in StandingDBP:>=20 mmHg(n= 49,9,11,6,19)
|
11 participants
|
2 participants
|
3 participants
|
2 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 30Population: 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.
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.
Outcome measures
| Measure |
L-Dopa
n=50 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=9 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=5 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
n=18 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Abnormalities
|
2 participants
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 30Population: 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.
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.
Outcome measures
| Measure |
L-Dopa
n=50 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=9 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=6 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
n=19 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Findings
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 30Population: 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.
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.
Outcome measures
| Measure |
L-Dopa
n=50 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=9 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=6 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
n=19 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Neurological Examination Abnormality
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 30Population: 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).
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").
Outcome measures
| Measure |
L-Dopa
n=9 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=6 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=19 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Number of Participants With Categorical Scores on The Columbia Suicide Severity Rating Scale (C-SSRS)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 13Population: 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).
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".
Outcome measures
| Measure |
L-Dopa
n=9 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=6 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=19 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
Total OFF time: Baseline (n=9,11,6,19)
|
4.42 hour
Standard Deviation 5.073
|
6.18 hour
Standard Deviation 3.433
|
6.75 hour
Standard Deviation 1.789
|
6.05 hour
Standard Deviation 3.981
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
Total OFF time: Change at Day 13 (n=9,9,3,9)
|
-0.14 hour
Standard Deviation 3.310
|
-0.31 hour
Standard Deviation 4.976
|
1.75 hour
Standard Deviation 2.646
|
-2.44 hour
Standard Deviation 6.335
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
Total ON time: Baseline (n=9,11,6,19)
|
11.92 hour
Standard Deviation 5.328
|
9.52 hour
Standard Deviation 3.665
|
8.13 hour
Standard Deviation 3.485
|
10.96 hour
Standard Deviation 4.862
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
Total ON time: Change at Day 13 (n=9,9,3,9)
|
1.86 hour
Standard Deviation 4.150
|
1.81 hour
Standard Deviation 6.644
|
-4.25 hour
Standard Deviation 0.750
|
0.06 hour
Standard Deviation 6.232
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
ON time WD: Baseline (n=9, 11, 6, 19)
|
7.58 hour
Standard Deviation 5.995
|
8.59 hour
Standard Deviation 2.996
|
4.13 hour
Standard Deviation 3.781
|
9.14 hour
Standard Deviation 5.950
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
ON time WD: Change at Day 13 (n=9, 9, 3, 9)
|
-1.50 hour
Standard Deviation 4.081
|
1.86 hour
Standard Deviation 6.519
|
-1.75 hour
Standard Deviation 3.031
|
-0.78 hour
Standard Deviation 4.604
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
ON time with dyskinesia: Baseline (n=9,11,6,19)
|
4.33 hour
Standard Deviation 5.851
|
0.93 hour
Standard Deviation 1.946
|
4.00 hour
Standard Deviation 3.698
|
1.82 hour
Standard Deviation 3.326
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
ON time with dyskinesia:Change at Day13(n=9,9,3,9)
|
3.36 hour
Standard Deviation 5.460
|
-0.06 hour
Standard Deviation 0.891
|
-2.50 hour
Standard Deviation 2.411
|
0.83 hour
Standard Deviation 6.294
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
ON time with TD: Baseline (n=9, 11, 6, 19)
|
1.56 hour
Standard Deviation 2.518
|
0.36 hour
Standard Deviation 0.876
|
0.29 hour
Standard Deviation 0.510
|
0.43 hour
Standard Deviation 1.833
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
ON time with TD: Change at Day 13 (n=9, 9, 3, 9)
|
1.58 hour
Standard Deviation 2.469
|
-0.14 hour
Standard Deviation 0.417
|
0.25 hour
Standard Deviation 0.433
|
-0.67 hour
Standard Deviation 2.000
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
Good ON time: Baseline (n=9, 11, 6, 19)
|
10.36 hour
Standard Deviation 5.053
|
9.16 hour
Standard Deviation 3.181
|
7.83 hour
Standard Deviation 3.319
|
10.53 hour
Standard Deviation 5.165
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
Good ON time: Change at Day 13 (n=9, 9, 3, 9)
|
0.28 hour
Standard Deviation 2.830
|
1.94 hour
Standard Deviation 6.690
|
-4.50 hour
Standard Deviation 1.146
|
0.72 hour
Standard Deviation 5.906
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
Total Awake time: Baseline (n=9, 11, 6, 19)
|
16.33 hour
Standard Deviation 1.620
|
15.70 hour
Standard Deviation 1.495
|
14.88 hour
Standard Deviation 2.602
|
17.01 hour
Standard Deviation 4.063
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
Total Awake time: Change at Day 13 (n=9, 9, 3, 9)
|
1.72 hour
Standard Deviation 1.748
|
1.50 hour
Standard Deviation 3.267
|
-2.50 hour
Standard Deviation 2.883
|
-2.39 hour
Standard Deviation 5.456
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
Total Asleep time: Baseline (n=9, 11, 6, 19)
|
7.67 hour
Standard Deviation 1.620
|
8.30 hour
Standard Deviation 1.495
|
7.92 hour
Standard Deviation 2.053
|
6.24 hour
Standard Deviation 2.895
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 13
Total Asleep time: Change at Day 13 (n=9, 9, 3, 9)
|
-1.72 hour
Standard Deviation 1.748
|
-1.50 hour
Standard Deviation 3.267
|
-0.33 hour
Standard Deviation 2.626
|
0.44 hour
Standard Deviation 0.982
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 20Population: 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).
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".
Outcome measures
| Measure |
L-Dopa
n=9 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=9 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=2 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=8 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 20
Total OFF time: Change at Day 20
|
1.97 hour
Standard Deviation 3.166
|
-0.19 hour
Standard Deviation 2.965
|
0.63 hour
Standard Deviation 4.419
|
-1.94 hour
Standard Deviation 5.603
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 20
Total ON time: Change at Day 20
|
-1.53 hour
Standard Deviation 3.556
|
0.69 hour
Standard Deviation 3.739
|
-0.63 hour
Standard Deviation 3.005
|
0.66 hour
Standard Deviation 6.518
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 20
ON time WD: Change at Day 20
|
-2.61 hour
Standard Deviation 3.814
|
1.06 hour
Standard Deviation 3.980
|
-2.13 hour
Standard Deviation 3.005
|
-0.41 hour
Standard Deviation 3.659
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 20
ON time with dyskinesia: Change at Day 20
|
1.08 hour
Standard Deviation 5.297
|
-0.36 hour
Standard Deviation 0.730
|
1.50 hour
Standard Deviation 6.010
|
1.06 hour
Standard Deviation 8.174
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 20
ON time with TD: Change at Day 20
|
0.47 hour
Standard Deviation 1.910
|
-0.08 hour
Standard Deviation 0.468
|
0.25 hour
Standard Deviation 0.000
|
-0.66 hour
Standard Deviation 1.856
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 20
Good ON time: Change at Day 20
|
-2.00 hour
Standard Deviation 2.613
|
0.78 hour
Standard Deviation 3.768
|
-0.88 hour
Standard Deviation 3.005
|
1.31 hour
Standard Deviation 6.088
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 20
Total Awake time: Change at Day 20
|
0.44 hour
Standard Deviation 1.116
|
0.50 hour
Standard Deviation 2.154
|
0.00 hour
Standard Deviation 1.414
|
-1.28 hour
Standard Deviation 1.538
|
—
|
|
Change From Baseline in Parkinson's Disease Diary For Participants With Motor Fluctuations at Day 20
Total Asleep time: Change at Day 20
|
-0.44 hour
Standard Deviation 1.116
|
-0.50 hour
Standard Deviation 2.154
|
0.00 hour
Standard Deviation 1.414
|
1.28 hour
Standard Deviation 1.538
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1Population: 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.
Outcome measures
| Measure |
L-Dopa
n=50 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of L-Dopa
|
2817 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 60
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1Population: 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.
Outcome measures
| Measure |
L-Dopa
n=50 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of L-Dopa
|
0.517 hour
Interval 0.417 to 8.25
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1Population: 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.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
L-Dopa
n=42 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of L-Dopa
|
33.57 liter per hour (L/hr)
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1Population: 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.
Terminal half-life is the time measured for the plasma concentration of drug to decrease by one half. It was calculated as dividing the natural logarithm to the base e (Log e)\*2/k el, where k el is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
L-Dopa
n=42 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of L-Dopa
|
1.534 hour
Standard Deviation 0.23847
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1Population: 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.
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
Outcome measures
| Measure |
L-Dopa
n=42 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero Extrapolated to Infinite Time of L-Dopa
|
6117 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 57
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1Population: 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.
Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (C last).
Outcome measures
| Measure |
L-Dopa
n=50 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration of L-Dopa
|
6152 ng*hr/mL
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose on Day 1Population: 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.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
L-Dopa
n=42 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of L-Dopa
|
73.41 Liter (L)
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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, 22Population: 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.
Outcome measures
| Measure |
L-Dopa
n=9 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=6 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=19 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-06649751
Day 7 (n =9, 9, 5, 14)
|
18.95 ng/mL
Geometric Coefficient of Variation 51
|
53.69 ng/mL
Geometric Coefficient of Variation 41
|
31.72 ng/mL
Geometric Coefficient of Variation 25
|
68.17 ng/mL
Geometric Coefficient of Variation 23
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-06649751
Day 13 (n =9, 7, 3, 5)
|
79.87 ng/mL
Geometric Coefficient of Variation 27
|
215.7 ng/mL
Geometric Coefficient of Variation 48
|
143.6 ng/mL
Geometric Coefficient of Variation 27
|
309.0 ng/mL
Geometric Coefficient of Variation 20
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-06649751
Day 22 (n =9, 7, 3, 7)
|
118.5 ng/mL
Geometric Coefficient of Variation 33
|
325.4 ng/mL
Geometric Coefficient of Variation 46
|
241.2 ng/mL
Geometric Coefficient of Variation 26
|
401.6 ng/mL
Geometric Coefficient of Variation 41
|
—
|
SECONDARY outcome
Timeframe: 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, 22Population: 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.
Outcome measures
| Measure |
L-Dopa
n=9 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=6 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=19 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06649751
Day 7 (n =9, 9, 5, 14)
|
1.00 hour
Interval 0.5 to 4.0
|
2.45 hour
Interval 1.03 to 4.15
|
2.00 hour
Interval 1.75 to 4.0
|
3.18 hour
Interval 0.5 to 11.6
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06649751
Day 13 (n =9, 7, 3, 1)
|
2.00 hour
Interval 0.833 to 12.0
|
3.92 hour
Interval 2.03 to 11.8
|
2.00 hour
Interval 2.0 to 4.0
|
8.00 hour
Interval 8.0 to 8.0
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06649751
Day 22 (n =9, 7, 3, 7)
|
2.00 hour
Interval 1.0 to 4.0
|
4.00 hour
Interval 2.0 to 12.0
|
2.02 hour
Interval 2.0 to 4.0
|
4.03 hour
Interval 1.97 to 8.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, 0.5, 1, 1.5, 2, 4, 8 and 12 hour post-dose on Day 22Population: 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.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
L-Dopa
n=9 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=7 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=3 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=7 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Apparent Clearance (CL/F) of PF-06649751
|
2.377 L/hr
Geometric Coefficient of Variation 35
|
2.504 L/hr
Geometric Coefficient of Variation 61
|
3.511 L/hr
Geometric Coefficient of Variation 40
|
3.483 L/hr
Geometric Coefficient of Variation 52
|
—
|
SECONDARY outcome
Timeframe: 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, 22Population: 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.
Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours.
Outcome measures
| Measure |
L-Dopa
n=9 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=6 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=19 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval of PF-06649751
Day 7 (n =9, 9, 5, 14)
|
261.9 ng*hr/mL
Geometric Coefficient of Variation 30
|
990.8 ng*hr/mL
Geometric Coefficient of Variation 56
|
530.9 ng*hr/mL
Geometric Coefficient of Variation 30
|
1203 ng*hr/mL
Geometric Coefficient of Variation 25
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval of PF-06649751
Day 13 (n =9, 7, 3, 5)
|
1438 ng*hr/mL
Geometric Coefficient of Variation 30
|
4192 ng*hr/mL
Geometric Coefficient of Variation 61
|
2414 ng*hr/mL
Geometric Coefficient of Variation 39
|
5498 ng*hr/mL
Geometric Coefficient of Variation 32
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval of PF-06649751
Day 22 (n =9, 7, 3, 7)
|
2105 ng*hr/mL
Geometric Coefficient of Variation 35
|
5993 ng*hr/mL
Geometric Coefficient of Variation 61
|
4271 ng*hr/mL
Geometric Coefficient of Variation 40
|
7182 ng*hr/mL
Geometric Coefficient of Variation 52
|
—
|
SECONDARY outcome
Timeframe: 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, 22Population: 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.
Outcome measures
| Measure |
L-Dopa
n=9 Participants
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=11 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=6 Participants
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=19 Participants
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Minimum Observed Plasma Trough Concentration (Cmin) of PF-06649751
Day 7 (n =9, 9, 5, 14)
|
7.295 ng/mL
Geometric Coefficient of Variation 30
|
27.97 ng/mL
Geometric Coefficient of Variation 66
|
14.19 ng/mL
Geometric Coefficient of Variation 38
|
24.29 ng/mL
Geometric Coefficient of Variation 36
|
—
|
|
Minimum Observed Plasma Trough Concentration (Cmin) of PF-06649751
Day 13 (n =9, 7, 3, 5)
|
35.00 ng/mL
Geometric Coefficient of Variation 69
|
132.5 ng/mL
Geometric Coefficient of Variation 77
|
65.19 ng/mL
Geometric Coefficient of Variation 56
|
162.3 ng/mL
Geometric Coefficient of Variation 37
|
—
|
|
Minimum Observed Plasma Trough Concentration (Cmin) of PF-06649751
Day 22 (n =9, 7, 3, 7)
|
68.14 ng/mL
Geometric Coefficient of Variation 44
|
197.9 ng/mL
Geometric Coefficient of Variation 78
|
120.8 ng/mL
Geometric Coefficient of Variation 68
|
215.1 ng/mL
Geometric Coefficient of Variation 63
|
—
|
SECONDARY outcome
Timeframe: 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, 22Population: Data was not collected since this outcome measure was not planned to be analyzed.
Rac was obtained from AUCtau after last dose divided by AUCtau after first dose, where AUC(tau) = Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 12 hours.
Outcome measures
Outcome data not reported
Adverse Events
L-Dopa
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-06649751 5 mg + L-Dopa
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
PF-06649751 15 mg + L-Dopa
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-06649751 25 mg + L-Dopa
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
L-Dopa
n=50 participants at risk
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=9 participants at risk
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=11 participants at risk
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=6 participants at risk
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
n=19 participants at risk
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
L-Dopa
n=50 participants at risk
Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator's discretion in Period 1.
|
PF-06649751 5 mg + L-Dopa
n=9 participants at risk
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
|
PF-06649751 15 mg + L-Dopa
n=11 participants at risk
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
|
PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)
n=6 participants at risk
Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
|
PF-06649751 25 mg + L-Dopa
n=19 participants at risk
Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator's decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Blepharospasm
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Photophobia
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Eye disorders
Vision blurred
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.5%
2/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
4/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
27.3%
3/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
42.1%
8/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
21.1%
4/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Asthenia
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Feeling cold
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Infusion site swelling
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Malaise
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
26.3%
5/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dystonia
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Freezing phenomenon
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
66.7%
6/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
63.6%
7/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
50.0%
3/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
42.1%
8/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Somnolence
|
2.0%
1/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Tremor
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
3/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
18.2%
2/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
15.8%
3/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.5%
2/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Dysphoria
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Insomnia
|
6.0%
3/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
3/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Nightmare
|
2.0%
1/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
33.3%
2/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
10.5%
2/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Sleep terror
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
22.2%
2/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hot flush
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
11.1%
1/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
16.7%
1/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/50 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/9 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
9.1%
1/11 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/6 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
5.3%
1/19 • Baseline (Day 1) up to Day 30
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER