Trial Outcomes & Findings for Clinical Trial In Healthy Volunteers And Health Elderly Volunteers To Evaluate The Safety, Tolerability And Blood Concentration After Single And Multiple Escalating Oral Doses Of PF-06751979. (NCT NCT02793232)
NCT ID: NCT02793232
Last Updated: 2018-09-17
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 was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient 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 and up to the follow up visit (up to 36 days in Part A, 49 days in Part B and C), that were absent before treatment or that worsened relative to pretreatment state.
COMPLETED
PHASE1
46 participants
Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
2018-09-17
Participant Flow
Study was conducted in 3 parts: Part A (4-period cross-over design), Part B and C (single period, parallel design).
Participant milestones
| Measure |
Part A- Placebo, PF-06751979: 400 mg, 540 mg, 200 mg Fed
Participants received oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 milligram (mg) suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
|
Part A-PF-06751979 200mg,Placebo,PF-06751979 540 mg,200 mg Fed
Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
|
Part A-PF-06751979: 200mg, 400mg,Placebo,PF-06751979 200mg Fed
Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
|
Part A- PF-06751979: 200 mg, 400 mg, 540 mg, Placebo
Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state. After completion of period 4, participants were followed for 10 days.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
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Period 1-Part A:5 Days; Part B,C:19 Days
STARTED
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Period 1-Part A:5 Days; Part B,C:19 Days
COMPLETED
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Period 1-Part A:5 Days; Part B,C:19 Days
NOT COMPLETED
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Washout Period 1(Part A:at Least 10days)
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Washout Period 1(Part A:at Least 10days)
COMPLETED
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Washout Period 1(Part A:at Least 10days)
NOT COMPLETED
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Period 2 (Part A: 5 Days)
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Period 2 (Part A: 5 Days)
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Period 2 (Part A: 5 Days)
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Washout Period 2(Part A:at Least 10days)
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Washout Period 2(Part A:at Least 10days)
COMPLETED
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Washout Period 2(Part A:at Least 10days)
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Period 3 (Part A: 5 Days)
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Period 3 (Part A: 5 Days)
COMPLETED
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Period 3 (Part A: 5 Days)
NOT COMPLETED
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Washout Period 3(Part A:at Least 10days)
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Washout Period 3(Part A:at Least 10days)
COMPLETED
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Washout Period 3(Part A:at Least 10days)
NOT COMPLETED
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Period 4 (Part A: 5 Days)
STARTED
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Period 4 (Part A: 5 Days)
COMPLETED
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Period 4 (Part A: 5 Days)
NOT COMPLETED
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Reasons for withdrawal
| Measure |
Part A- Placebo, PF-06751979: 400 mg, 540 mg, 200 mg Fed
Participants received oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 milligram (mg) suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
|
Part A-PF-06751979 200mg,Placebo,PF-06751979 540 mg,200 mg Fed
Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
|
Part A-PF-06751979: 200mg, 400mg,Placebo,PF-06751979 200mg Fed
Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
|
Part A- PF-06751979: 200 mg, 400 mg, 540 mg, Placebo
Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state. After completion of period 4, participants were followed for 10 days.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|
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Period 1-Part A:5 Days; Part B,C:19 Days
Adverse Event
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0
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0
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0
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0
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1
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0
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1
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0
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0
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Baseline Characteristics
Clinical Trial In Healthy Volunteers And Health Elderly Volunteers To Evaluate The Safety, Tolerability And Blood Concentration After Single And Multiple Escalating Oral Doses Of PF-06751979.
Baseline characteristics by cohort
| Measure |
Part A- Placebo, PF-06751979: 400 mg, 540 mg, 200 mg Fed
n=2 Participants
Participants received oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 milligram (mg) suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
|
Part A-PF-06751979 200mg,Placebo,PF-06751979 540 mg,200 mg Fed
n=2 Participants
Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
|
Part A-PF-06751979: 200mg, 400mg,Placebo,PF-06751979 200mg Fed
n=2 Participants
Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 3 followed by an oral dose of PF-06751979 200 mg suspension under fed condition on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state except PF-06751979 200 mg Fed. After completion of period 4, participants were followed for 10 days.
|
Part A- PF-06751979: 200 mg, 400 mg, 540 mg, Placebo
n=2 Participants
Participants received oral dose of PF-06751979 200 mg suspension on Day 1 of intervention period 1 followed by oral dose of PF-06751979 400 mg suspension on Day 1 of intervention period 2 followed by oral dose of PF-06751979 540 mg suspension on Day 1 of intervention period 3 followed by oral dose of placebo matched to PF-06751979 on Day 1 of intervention period 4. A washout period of at least 10 days was maintained between each intervention period. All doses were administered in fasted state. After completion of period 4, participants were followed for 10 days.
|
Part B: Placebo
n=7 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
n=12 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
n=9 Participants
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
n=2 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
n=8 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Total
n=46 Participants
Total of all reporting groups
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|---|---|---|---|---|---|---|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=62 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=8 Participants
|
38 Participants
n=62 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=62 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
12 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
42 Participants
n=62 Participants
|
PRIMARY outcome
Timeframe: Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient 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 and up to the follow up visit (up to 36 days in Part A, 49 days in Part B and C), that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
n=7 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
n=12 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
n=9 Participants
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
n=2 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
n=8 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
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|---|---|---|---|---|---|---|---|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
1 participants
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3 participants
|
2 participants
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6 participants
|
4 participants
|
6 participants
|
10 participants
|
8 participants
|
2 participants
|
6 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 participants
|
0 participants
|
0 participants
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0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
Full physical examination included head, ears, eyes, nose, mouth, skin, heart, lung, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Abnormality in physical examinations was based on investigator's discretion.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
n=7 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
n=12 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
n=9 Participants
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
n=2 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
n=8 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
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Number of Participants With Abnormal Physical Examinations Findings
|
1 participants
|
5 participants
|
0 participants
|
0 participants
|
0 participants
|
6 participants
|
8 participants
|
5 participants
|
0 participants
|
4 participants
|
PRIMARY outcome
Timeframe: Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
The neurological examination included the assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait. Abnormality in neurological examinations was based on investigator's discretion.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
n=7 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
n=12 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
n=9 Participants
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
n=2 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
n=8 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Neurological Examinations Findings
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.
C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), 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, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at baseline were reported.
Outcome measures
| Measure |
Part A: Placebo
n=7 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=12 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=9 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=2 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=8 Participants
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 7Population: Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.
C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), 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, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 7 were reported.
Outcome measures
| Measure |
Part A: Placebo
n=7 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=12 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=9 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=2 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=8 Participants
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 7
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 14Population: Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.
C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), 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, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 14 were reported.
Outcome measures
| Measure |
Part A: Placebo
n=7 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=12 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=9 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=2 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=8 Participants
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 14
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 19Population: Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part A, as pre-specified in protocol.
C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide; suicide attempt (response of "Yes" on "actual attempt"); preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior", "aborted attempt" or "interrupted attempt"), 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, any self-injurious behavior with no suicidal intent). In this outcome measure, number of participants with positive response (response of "yes") to suicidal behavior, ideation or any non-suicidal self-injurious behavior, at Day 19 were reported.
Outcome measures
| Measure |
Part A: Placebo
n=7 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=12 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=9 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=2 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=8 Participants
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B and C: Number of Participants With Positive Response on the Columbia Suicide Severity Rating Scale (C-SSRS) at Day 19
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
Criteria for abnormal values of ECG parameters: maximum pulse rate (PR) interval greater than or equal to (\>=)300 milliseconds (msec); maximum PR interval increase from baseline (IFB): \>=25 percent (%) when baseline was greater than (\>)200 msec; or \>=50 % when baseline was greater than (\>)200 msec, maximum QRS interval \>=140 msec and QRS interval IFB: \>=50%. QT interval using Fridericia's correction (QTcF) ranges from 450 msec to maximum less than (\<)480 msec, less than or equal to (\<=) 480 msec to maximum \<500 msec and maximum \>=500 msec, maximum QTcF interval IFB range from \<=30 to \<60 msec and maximum \>=60 msec. Only categories which included at least 1 participant with abnormality are reported in this outcome measure.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
n=7 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
n=12 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
n=9 Participants
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
n=2 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
n=8 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Maximum QTCF Interval: 450 to <480 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Maximum QTCF Interval IFB: <=30 to <60 msec
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Day 1Population: Safety analysis set included all participants who received at least 1 dose of study medication. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.
In all Periods of Part A, continuous cardiac monitoring was maintained for 8 hours (or longer if considered clinically necessary by the investigator) following dose administration on Day 1. All abnormal cardiac rhythms were recorded and reviewed by the study physician for the presence of rhythms of potential clinical concern.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Cardiac Rhythms of Potential Clinical Concern Assessed By Telemetry
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
Criteria for vital signs abnormalities: systolic blood pressure (SBP) \<90 millimeter of mercury (mmHg), diastolic blood pressure (DBP) \<50 mmHg, supine pulse rate \<40 beats per minute (bpm). Maximum IFB in Supine SBP \>=30 mmHg, Maximum decrease from baseline (DFB) in Supine SBP \>=30 mmHg, maximum DFB in Supine DBP \>=20 mmHg.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
n=7 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
n=12 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
n=9 Participants
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
n=2 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
n=8 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Sign Abnormalities
Supine SBP: <90 mmHg
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Vital Sign Abnormalities
Supine DBP: <50 mmHg
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Vital Sign Abnormalities
Supine PR: <40 bpm
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Vital Sign Abnormalities
Maximum IFB in Supine SBP: >=30 mmHg
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Vital Sign Abnormalities
Maximum DFB in Supine SBP: >=30 mmHg
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Vital Sign Abnormalities
Maximum DFB in Supine DBP: >=20 mmHg
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 daysPopulation: Safety analysis set included all participants who received at least 1 dose of study medication.
Abnormalities criteria:hematology(hemoglobin; hematocrit; RBC\<0.8\*lower limit of normal \[LLN\]; platelets\<0.5\*LLN,\>1.75\*upper limit of normal \[ULN\]; WBC\<0.6\*LLN,\>1.5\*ULN; lymphocytes; neutrophils; basophils; eosinophils; monocytes\<0.8\*LLN,\>1.2\*ULN; coagulation(prothrombin ratio\>1.1\*ULN), liver(bilirubin\>1.5\*ULN; aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase; gamma GT\>0.3\*ULN; protein; albumin\<0.8\*LLN,\>1.2\*ULN); renal(blood urea nitrogen, creatinine\>1.3\*ULN; uric acid\>1.2\*ULN); electrolytes(sodium\<0.95\*LLN,\>1.05\*ULN; potassium; chloride; calcium; bicarbonate\<0.9\*LLN,\>1.1\*ULN), chemistry(glucose\<0.6\*LLN,\>1.5\* ULN); urinalysis(pH \<4.5,\>8; glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte, esterase\>1; WBC; bacteria\>=20, epithelial cells\>=6; granular casts, hyaline casts, red cell casts, white cell casts\>1; lipids(cholesterol\[C\], LDL-C\>1.3\*ULN; HDL-C\<0.8\*LLN, triglycerides\>1.3\*ULN); hormones(T4, T3, T4, TSH\<0.8\*LLN,\>1.2\*ULN).
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
n=7 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
n=12 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
n=9 Participants
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
n=2 Participants
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
n=8 Participants
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities
|
6 participants
|
5 participants
|
2 participants
|
3 participants
|
5 participants
|
5 participants
|
11 participants
|
8 participants
|
1 participants
|
7 participants
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1Population: Pharmacokinetic (PK) parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
|
643.2 nanogram per milliliter
Geometric Coefficient of Variation 19
|
1436 nanogram per milliliter
Geometric Coefficient of Variation 10
|
1829 nanogram per milliliter
Geometric Coefficient of Variation 19
|
630.2 nanogram per milliliter
Geometric Coefficient of Variation 9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.
Area under the plasma concentration-time profile from time zero to the time of last measured concentration (AUClast).
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUClast) of PF-06751979
|
20500 nanogram*hour per milliliter
Geometric Coefficient of Variation 19
|
41710 nanogram*hour per milliliter
Geometric Coefficient of Variation 18
|
58190 nanogram*hour per milliliter
Geometric Coefficient of Variation 14
|
20170 nanogram*hour per milliliter
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06751979
|
22850 nanogram*hour per milliliter
Geometric Coefficient of Variation 17
|
44980 nanogram*hour per milliliter
Geometric Coefficient of Variation 17
|
63420 nanogram*hour per milliliter
Geometric Coefficient of Variation 9
|
23260 nanogram*hour per milliliter
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in milligram) administered to a participant.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979
|
3.218 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 19
|
3.592 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 10
|
3.387 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 19
|
3.154 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 9
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.
AUClast(dn) was calculated by dividing AUClast by the exact dose of PF-06751979 (in mg) administered to a participant. AUClast was area under the plasma concentration-time profile from time zero to the time of last measured concentration.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06751979
|
102.6 (nanogram*hour/milliliter) per milligram
Geometric Coefficient of Variation 19
|
104.2 (nanogram*hour/milliliter) per milligram
Geometric Coefficient of Variation 18
|
107.9 (nanogram*hour/milliliter) per milligram
Geometric Coefficient of Variation 14
|
100.9 (nanogram*hour/milliliter) per milligram
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part B and C, as pre specified in protocol.
AUCinf (dn) was calculated by dividing AUCinf by the exact dose of PF-06751979 (in mg) administered to a participant. AUCinf was area under the plasma concentration-time profile from time zero extrapolated to infinite time (0-inf).
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Dose Normalized Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf [dn]) of PF-06751979
|
114.1 (nanogram*hour/milliliter) per milligram
Geometric Coefficient of Variation 17
|
112.4 (nanogram*hour/milliliter) per milligram
Geometric Coefficient of Variation 17
|
117.6 (nanogram*hour/milliliter) per milligram
Geometric Coefficient of Variation 9
|
116.4 (nanogram*hour/milliliter) per milligram
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
|
4.00 hours
Full Range 17 • Interval 2.0 to 6.07
|
3.02 hours
Full Range 17 • Interval 2.0 to 4.0
|
3.01 hours
Full Range 9 • Interval 2.0 to 6.02
|
6.00 hours
Full Range 15 • Interval 4.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Plasma decay half-life is the time duration for the plasma concentration of PF-06751979 to decrease by one-half of its original concentration.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Plasma Decay Half-Life (t1/2) of PF-06751979
|
35.20 hours
Standard Deviation 8.9731 • Interval 2.0 to 6.07
|
34.70 hours
Standard Deviation 8.9749 • Interval 2.0 to 4.0
|
35.85 hours
Standard Deviation 8.1028 • Interval 2.0 to 6.02
|
33.38 hours
Standard Deviation 6.2474 • Interval 4.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Apparent Clearance (CL/F) of PF-06751979
|
145.8 milliliter per minute
Geometric Coefficient of Variation 17 • Interval 2.0 to 6.07
|
148.3 milliliter per minute
Geometric Coefficient of Variation 17 • Interval 2.0 to 4.0
|
142.0 milliliter per minute
Geometric Coefficient of Variation 9 • Interval 2.0 to 6.02
|
143.3 milliliter per minute
Geometric Coefficient of Variation 15 • Interval 4.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours post dose on Day 1Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
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 blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 Participants
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Apparent Volume of Distribution (Vz/F) of PF-06751979
|
433.7 Liter
Geometric Coefficient of Variation 18 • Interval 2.0 to 6.07
|
433.0 Liter
Geometric Coefficient of Variation 19 • Interval 2.0 to 4.0
|
431.1 Liter
Geometric Coefficient of Variation 19 • Interval 2.0 to 6.02
|
408.1 Liter
Geometric Coefficient of Variation 16 • Interval 4.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time points for each arm.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=9 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
Day 1
|
442.7 nanogram per milliliter
Geometric Coefficient of Variation 20
|
983.2 nanogram per milliliter
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
Day 7
|
818.7 nanogram per milliliter
Geometric Coefficient of Variation 19
|
2000 nanogram per milliliter
Geometric Coefficient of Variation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
Day 14
|
837.6 nanogram per milliliter
Geometric Coefficient of Variation 16
|
1869 nanogram per milliliter
Geometric Coefficient of Variation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14Population: Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=9 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979
Day 1
|
6380 nanogram*hour per milliliter
Geometric Coefficient of Variation 15
|
13260 nanogram*hour per milliliter
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979
Day 7
|
13810 nanogram*hour per milliliter
Geometric Coefficient of Variation 16
|
31210 nanogram*hour per milliliter
Geometric Coefficient of Variation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979
Day 14
|
13990 nanogram*hour per milliliter
Geometric Coefficient of Variation 14
|
29470 nanogram*hour per milliliter
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=9 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
Day 1
|
4.00 hours
Interval 2.0 to 6.03
|
4.00 hours
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
Day 7
|
3.00 hours
Interval 2.0 to 6.0
|
2.00 hours
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
Day 14
|
4.00 hours
Interval 2.0 to 12.0
|
4.00 hours
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm.
Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered to a participant.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=9 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979
Day 1
|
3.541 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 20
|
3.576 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979
Day 7
|
6.549 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 19
|
7.272 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979
Day 14
|
6.702 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 16
|
6.794 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14Population: Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. AUCtau (dn) was calculated by dividing AUCtau by the exact dose of PF-06751979 (in mg) administered to a participant.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=9 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau[dn]) of PF-06751979
Day 1
|
51.04 (nanogram*hour/milliliter)/milligram
Geometric Coefficient of Variation 15
|
48.21 (nanogram*hour/milliliter)/milligram
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau[dn]) of PF-06751979
Day 7
|
110.4 (nanogram*hour/milliliter)/milligram
Geometric Coefficient of Variation 16
|
113.5 (nanogram*hour/milliliter)/milligram
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau[dn]) of PF-06751979
Day 14
|
111.8 (nanogram*hour/milliliter)/milligram
Geometric Coefficient of Variation 14
|
107.1 (nanogram*hour/milliliter)/milligram
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number analyzed signifies those participants who were evaluable at specified time point for each arm.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=9 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Apparent Clearance (CL/F) of PF-06751979
Day 7
|
151.0 milliliter per minute
Geometric Coefficient of Variation 16
|
146.9 milliliter per minute
Geometric Coefficient of Variation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Apparent Clearance (CL/F) of PF-06751979
Day 14
|
149.0 milliliter per minute
Geometric Coefficient of Variation 14
|
155.3 milliliter per minute
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=9 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Minimum Observed Plasma Concentration (Cmin) of PF-06751979
Day 7
|
388.4 nanogram per milliliter
Geometric Coefficient of Variation 17
|
857.3 nanogram per milliliter
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Minimum Observed Plasma Concentration (Cmin) of PF-06751979
Day 14
|
390.3 nanogram per milliliter
Geometric Coefficient of Variation 18
|
868.5 nanogram per milliliter
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Peak-to-trough ratio was calculated by dividing Cmax with Cmin of PF-06751979. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=9 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Peak-to-Trough Ratio of PF-06751979
Day 7
|
2.111 ratio
Geometric Coefficient of Variation 10
|
2.332 ratio
Geometric Coefficient of Variation 8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Peak-to-Trough Ratio of PF-06751979
Day 14
|
2.145 ratio
Geometric Coefficient of Variation 11
|
2.151 ratio
Geometric Coefficient of Variation 9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14Population: Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Rac for AUCtau for Day 7 was calculated as: AUCtau on Day 7 divided by AUCtau on Day 1. Rac for AUCtau for Day 14 was calculated as: AUCtau on Day 14 divided by AUCtau on Day 1.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=9 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979
Day 7
|
2.165 ratio
Geometric Coefficient of Variation 9
|
2.355 ratio
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979
Day 14
|
2.190 ratio
Geometric Coefficient of Variation 11
|
2.265 ratio
Geometric Coefficient of Variation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 7; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: Analysis was performed on PK parameter analysis set. Number analyzed= participants evaluable at specified time points for each arm. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Rac for Cmax on Day 7 was calculated as: Cmax on Day 7 divided by Cmax on Day 1 and Rac for Cmax on Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=9 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979
Day 7
|
1.849 ratio
Geometric Coefficient of Variation 16
|
2.033 ratio
Geometric Coefficient of Variation 7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979
Day 14
|
1.892 ratio
Geometric Coefficient of Variation 14
|
1.923 ratio
Geometric Coefficient of Variation 9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number of participants analyzed signifies those participants who were evaluable for this outcome measure.
Plasma decay half-life is the time duration for the plasma concentration of PF-06751979 to decrease by one-half of its original concentration.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=8 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Plasma Decay Half-Life (t1/2) of PF-06751979
|
30.73 hour
Standard Deviation 5.7464 • Interval 2.0 to 12.0
|
37.79 hour
Standard Deviation 7.7261 • Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Here, number of participants analyzed 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 blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=8 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Apparent Volume of Distribution (Vz/F) of PF-06751979
|
390.5 Liter
Geometric Coefficient of Variation 23 • Interval 2.0 to 12.0
|
498.3 Liter
Geometric Coefficient of Variation 27 • Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
Day 1
|
377.1 nanogram per milliliter
Geometric Coefficient of Variation 30 • Interval 2.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Maximum Observed Plasma Concentration (Cmax) of PF-06751979
Day 14
|
879.4 nanogram per milliliter
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Area under the plasma concentration versus time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979
Day 1
|
5238 nanogram*hour per milliliter
Geometric Coefficient of Variation 24 • Interval 2.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06751979
Day 14
|
14750 nanogram*hour per milliliter
Geometric Coefficient of Variation 23
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
Day 1
|
4.00 hours
Full Range 24 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06751979
Day 14
|
4.00 hours
Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Cmax(dn) was obtained calculated by dividing Cmax by the exact dose of PF-06751979 (in mg) administered to a participant.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979
Day 1
|
3.019 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 30 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06751979
Day 14
|
7.035 (nanogram per milliliter) per milligram
Geometric Coefficient of Variation 28 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Area under the concentration curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours. AUCtau (dn) was calculated by dividing AUCtau by the exact dose of PF-06751979 (in mg) administered to a participant.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau[dn]) of PF-06751979
Day 1
|
41.93 (nanogram*hour/milliliter)/milligram
Geometric Coefficient of Variation 24 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval Tau (AUCtau[dn]) of PF-06751979
Day 14
|
118.0 (nanogram*hour/milliliter)/milligram
Geometric Coefficient of Variation 23 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Apparent Oral Clearance (CL/F)
|
141.4 milliliter per minute
Geometric Coefficient of Variation 23 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Minimum observed concentration during the dosing interval.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Minimum Observed Plasma Concentration (Cmin) of PF-06751979
|
429.9 nanogram per milliliter
Geometric Coefficient of Variation 23 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Peak-to-trough ratio was calculated by dividing Cmax with Cmin of PF-06751979. Cmax was maximum plasma concentration during the dosing interval and Cmin was minimum observed plasma concentration during the dosing interval.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Peak-to-Trough Ratio of PF-06751979
|
2.045 ratio
Geometric Coefficient of Variation 10 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Rac for AUCtau at Day 14 was calculated as: AUCtau on Day 14 divided by AUCtau on Day 1.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Observed Accumulation Ratio (Rac) for AUCtau of PF-06751979
|
2.814 ratio
Geometric Coefficient of Variation 3 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post dose on Day 1; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured. Data for this outcome measure was not planned to be analyzed for Part A, as pre specified in protocol.
Rac for Cmax on Day 14 was calculated as: Cmax on Day 14 divided by Cmax on Day 1, where Cmax was the maximum observed plasma concentration.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac Cmax) of PF-06751979
|
2.332 ratio
Geometric Coefficient of Variation 7 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
Plasma decay half-life was the time duration for the plasma concentration to decrease by one-half of its original concentration.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Plasma Decay Half-Life (t1/2) of PF-06751979
|
40.76 hours
Standard Deviation 3.9042 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours post dose on Day 14Population: PK parameter analysis set included all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.
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 blood concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Apparent Volume of Distribution (Vz/F) of PF-06751979
|
496.1 Liter
Geometric Coefficient of Variation 30 • Interval 2.0 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-24 hours on Day 14Population: PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol.
Aetau was the amount of drug excreted unchanged in urine during the dosing interval tau, where tau was 24 hours.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=8 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Amount of PF-06751979 Excreted Unchanged in Urine Over the Dosing Interval Tau (Aetau)
|
12.93 milligram
Geometric Coefficient of Variation 38
|
25.93 milligram
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-24 hours on Day 14Population: PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol.
Aetau% was calculated as: 100\*Aetau/dose. Aetau was the amount of drug excreted unchanged in urine during the dosing interval tau, where tau was 24 hours.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=8 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Percentage of Dose of PF-06751979 Excreted Unchanged in the Urine Over the Dosing Interval Tau (Aetau%)
|
10.36 percentage of dose excreated
Geometric Coefficient of Variation 38
|
9.429 percentage of dose excreated
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 0-24 hours on Day 14Population: PK parameter analysis set =all enrolled participants who had at least 1 dose of PF-06751979 and at least of the PK parameters of interest measured.Here, number of participants analyzed =participants who were evaluable for this outcome measure.Data for this outcome measure was not planned to be analyzed for Part A and C,as pre specified in protocol.
Renal clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated in urine. It was calculated as amount of drug excreted unchanged in urine during the dosing interval tau (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours.
Outcome measures
| Measure |
Part A: Placebo
n=9 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=8 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Renal Clearance of PF-06751979
|
15.54 milliliter per minute
Geometric Coefficient of Variation 37
|
14.68 milliliter per minute
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14Population: Pharmacodynamic CSF concentration population: all enrolled and treated participants who had at least 1 measureable CSF ABeta concentration. Number of participants analyzed= participants who were evaluable for this outcome measure. Data for this outcome measure was not planned to be analyzed for Part A and C, as pre specified in protocol.
ABeta is the peptide fragment of the amyloid precursor protein. Percent change from baseline in CSF concentration of ABeta fragments (ABeta 1-38, ABeta 1-40, ABeta 1-42, ABeta total, ABeta x-38, ABeta x-40, ABeta x-42, soluble amyloid precursor protein alpha (sAPP-alpha), soluble amyloid precursor protein beta (sAPP-beta) at Day 14 was reported in this outcome measure.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=12 Participants
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=8 Participants
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: Placebo
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments
ABeta 1-38
|
-4.223 percent change
Standard Error 0.0669
|
-80.324 percent change
Standard Error 0.0472
|
-87.935 percent change
Standard Error 0.0579
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments
ABeta 1-40
|
-10.031 percent change
Standard Error 0.0746
|
-85.452 percent change
Standard Error 0.0536
|
-92.927 percent change
Standard Error 0.0689
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments
ABeta 1-42
|
-10.335 percent change
Standard Error 0.0789
|
-86.383 percent change
Standard Error 0.0587
|
-93.607 percent change
Standard Error 0.0758
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments
ABeta x-38
|
-12.362 percent change
Standard Error 0.0708
|
-82.003 percent change
Standard Error 0.0513
|
-90.106 percent change
Standard Error 0.0643
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments
ABeta x-40
|
-9.785 percent change
Standard Error 0.0673
|
-80.998 percent change
Standard Error 0.0478
|
-87.622 percent change
Standard Error 0.0591
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments
ABeta x-42
|
-10.874 percent change
Standard Error 0.0539
|
-81.861 percent change
Standard Error 0.0385
|
-86.618 percent change
Standard Error 0.0472
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments
sAPP-alpha
|
-8.237 percent change
Standard Error 0.0655
|
58.653 percent change
Standard Error 0.0480
|
81.737 percent change
Standard Error 0.0604
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments
sAPP-beta
|
-5.553 percent change
Standard Error 0.0545
|
-81.266 percent change
Standard Error 0.0390
|
-84.304 percent change
Standard Error 0.0485
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Percent Change From Baseline in Cerebrospinal Spinal Fluid (CSF) Amyloid Beta (ABeta) Fragments
ABeta total
|
-7.911 percent change
Standard Error 0.0492
|
-80.116 percent change
Standard Error 0.0348
|
-86.523 percent change
Standard Error 0.0428
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: Placebo
Part A: PF-06751979 200 mg
Part A: PF-06751979 400 mg
Part A: PF-06751979 540 mg
Part A: PF-06751979 200 mg Fed
Part B: Placebo
Part B: PF-06751979 125 mg
Part B: PF-06751979 275 mg
Part C: Placebo
Part C: PF-06751979 125 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Placebo
n=8 participants at risk
All participants who received oral dose of placebo matched to PF-06751979 in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg
n=6 participants at risk
All participants who received oral dose of PF-06751979 200 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 400 mg
n=6 participants at risk
All participants who received oral dose of PF-06751979 400 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 540 mg
n=6 participants at risk
All participants who received oral dose of PF-06751979 540 mg suspension in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part A: PF-06751979 200 mg Fed
n=6 participants at risk
All participants who received oral dose of PF-06751979 200 mg suspension under fed condition in either 1 of the 4 intervention periods in Part A of the study. A washout period of at least 10 days was maintained between each intervention period.
|
Part B: Placebo
n=7 participants at risk
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 125 mg
n=12 participants at risk
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part B: PF-06751979 275 mg
n=9 participants at risk
Participants received oral dose of PF-06751979 275 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication
|
Part C: Placebo
n=2 participants at risk
Participants received oral dose of placebo matched to PF-06751979 suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
Part C: PF-06751979 125 mg
n=8 participants at risk
Participants received oral dose of PF-06751979 125 mg suspension once daily from Day 1 up to Day 14 in intervention period of 19 days. Participants were followed up to 15 days (up to Day 29) after last dose of study medication.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Eye disorders
Visual impairment
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
General disorders
Discomfort
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
General disorders
Fatigue
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
33.3%
2/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
2/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
General disorders
Hunger
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
General disorders
Vessel puncture site erythema
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
8.3%
1/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Infections and infestations
Ear infection
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Infections and infestations
Folliculitis
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Infections and infestations
Hordeolum
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
2/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
50.0%
1/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
33.3%
2/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
28.6%
2/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
25.0%
3/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Vascular disorders
Hot flush
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
1/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Eye disorders
Blepharospasm
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Eye disorders
Eye movement disorder
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
50.0%
1/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
8.3%
1/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
General disorders
Malaise
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
8.3%
1/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
8.3%
1/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
8.3%
1/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
16.7%
2/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
25.0%
3/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
22.2%
2/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
50.0%
1/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
8.3%
1/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
8.3%
1/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
8.3%
1/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
50.0%
1/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Psychiatric disorders
Daydreaming
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
8.3%
1/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
8.3%
1/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
33.3%
3/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
12.5%
1/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
11.1%
1/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
|
Vascular disorders
Haematoma
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/6 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
14.3%
1/7 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/12 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/9 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/2 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
0.00%
0/8 • Part A: Baseline up to 36 days; Part B and C: Baseline up to 49 days
|
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