Trial Outcomes & Findings for A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib (NCT NCT02334800)
NCT ID: NCT02334800
Last Updated: 2018-01-24
Results Overview
AUCinf is area under the plasma concentration time curve from time 0 extrapolated infinite time. It is calculated as AUClast + (Clast/kel), where AUClast is area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.
Results posted on
2018-01-24
Participant Flow
A total of 28 participants were assigned to and received the study treatment (7 participants in each cohort).
Participant milestones
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
7
|
7
|
|
Overall Study
Received Treatment
|
7
|
7
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
Baseline characteristics by cohort
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
53.9 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
57 years
STANDARD_DEVIATION 5.3 • n=4 Participants
|
56.6 years
STANDARD_DEVIATION 4.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.
AUCinf is area under the plasma concentration time curve from time 0 extrapolated infinite time. It is calculated as AUClast + (Clast/kel), where AUClast is area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, Clast is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf)
|
1031 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24
|
758.9 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
1189 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22
|
1378 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
PRIMARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics concentration population was defined as all participants enrolled and treated who had at least 1 palbociclib concentration.
Cmax is maximum plasma concentration. It is observed directly from data.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
28.64 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
27.20 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
33.72 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
37.20 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 48
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.
AUCinf,u is unbound AUCinf, where AUCinf is area under the concentration-time curve from time 0 extrapolated to infinite time. It is obtained by fu\*AUCinf, where fu is the fraction of unbound drug in plasma.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Unbound AUCinf (AUCinf,u)
|
196.6 ng*hr/mL
Geometric Coefficient of Variation 26
|
163.2 ng*hr/mL
Geometric Coefficient of Variation 32
|
264.1 ng*hr/mL
Geometric Coefficient of Variation 25
|
347.8 ng*hr/mL
Geometric Coefficient of Variation 23
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.
AUClast is area under the plasma concentration time curve from time 0 to time of last quantifiable concentration. It is obtained from linear/log trapezoidal method.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)
|
973.3 ng*hr/mL
Geometric Coefficient of Variation 24
|
708.6 ng*hr/mL
Geometric Coefficient of Variation 34
|
1125 ng*hr/mL
Geometric Coefficient of Variation 24
|
1311 ng*hr/mL
Geometric Coefficient of Variation 31
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.
AUClast,u is unbound AUClast, where AUClast is area under the concentration-time curve from time 0 to the time of the last quantifiable concentration. It is obtained by fu\*AUClast, where fu is the fraction of unbound drug in plasma.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Unbound AUClast (AUClast,u)
|
185.5 ng*hr/mL
Geometric Coefficient of Variation 26
|
152.4 ng*hr/mL
Geometric Coefficient of Variation 35
|
250.3 ng*hr/mL
Geometric Coefficient of Variation 26
|
331.0 ng*hr/mL
Geometric Coefficient of Variation 24
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance is obtained by dose/AUCinf, where AUCinf is the area under the concentration-time curve from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Apparent Clearance After Oral Dose(CL/F)
|
72.64 liter/hour (L/hr)
Geometric Coefficient of Variation 24
|
98.84 liter/hour (L/hr)
Geometric Coefficient of Variation 31
|
63.15 liter/hour (L/hr)
Geometric Coefficient of Variation 22
|
54.42 liter/hour (L/hr)
Geometric Coefficient of Variation 29
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.
CLu/F is unbound CL/F, where CL/F is apparent clearance after oral dose. It is obtained by dose/AUCinf,u, where AUCinf,u is unbound AUCinf (area under the concentration-time curve from time 0 extrapolated to infinite time).
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Unbound CL/F (CLu/F)
|
381.3 L/hr
Geometric Coefficient of Variation 26
|
459.2 L/hr
Geometric Coefficient of Variation 32
|
283.8 L/hr
Geometric Coefficient of Variation 25
|
215.8 L/hr
Geometric Coefficient of Variation 23
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.
Cmax,u is unbound Cmax, where Cmax is maximum plasma concentration. It is obtained by fu\*Cmax, where fu is fraction of unbound drug in plasma.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Unbound Cmax (Cmax,u)
|
5.456 ng/mL
Geometric Coefficient of Variation 23
|
5.858 ng/mL
Geometric Coefficient of Variation 37
|
7.501 ng/mL
Geometric Coefficient of Variation 34
|
9.399 ng/mL
Geometric Coefficient of Variation 47
|
SECONDARY outcome
Timeframe: Eight (8) hours post-dose.Population: The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.
Fu is the fraction of unbound drug in plasma. It is obtained from measurement of protein binding.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Fraction of Unbound Drug in Plasma (fu)
|
0.1910 ratio
Standard Deviation 0.015
|
0.2157 ratio
Standard Deviation 0.014
|
0.2236 ratio
Standard Deviation 0.025
|
0.2546 ratio
Standard Deviation 0.036
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.
T1/2 is terminal half-life. It is obtained by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Terminal Half-Life (t1/2)
|
25.84 hour (hr)
Standard Deviation 4.22
|
27.23 hour (hr)
Standard Deviation 5.49
|
35.03 hour (hr)
Standard Deviation 4.61
|
33.84 hour (hr)
Standard Deviation 5.39
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics concentration population was defined as all participants enrolled and treated who had at least 1 palbociclib concentration
Tmax is time for maximum plasma concentration. It is observed directly from data as time of first occurrence of maximum plasma concentration.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Time for Cmax (Tmax)
|
8.00 hr
Interval 6.0 to 12.0
|
6.00 hr
Interval 6.0 to 6.0
|
6.00 hr
Interval 2.0 to 6.0
|
6.00 hr
Interval 2.0 to 8.0
|
SECONDARY outcome
Timeframe: pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.
Vz/F is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. It is influenced by the fraction absorbed. It is obtained by dose/(AUCinf•kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, and AUCinf is the area under the concentration-time curve from time 0 extrapolated to infinite time.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Apparent Volunm of Distribution After Oral Dose (Vz/F)
|
2679 liter (L)
Geometric Coefficient of Variation 18
|
3814 liter (L)
Geometric Coefficient of Variation 36
|
3168 liter (L)
Geometric Coefficient of Variation 26
|
2627 liter (L)
Geometric Coefficient of Variation 29
|
SECONDARY outcome
Timeframe: Pre-dose and 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose for for all participants. Additional pharmacokinetics samples were collected from participants in hepatic impairment cohorts (Cohorts 2, 3 and 4) at 144, 168, and 192 hours post-dose.Population: The pharmacokinetics parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the palbociclib pharmacokinetics parameters of primary interest.
Vz,u/F is unbound Vz/F, where Vz/F is apparent volume of distribution after oral dose. It is obtained by dose/(AUCinf,u\*kel), where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve, and AUCinf,u is unbound AUCinf (area under the concentration-time curve from time 0 extrapolated to infinite time).
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Unbound Vz/F (Vz,u/F)
|
14060 L
Geometric Coefficient of Variation 24
|
17730 L
Geometric Coefficient of Variation 36
|
14260 L
Geometric Coefficient of Variation 32
|
10410 L
Geometric Coefficient of Variation 30
|
SECONDARY outcome
Timeframe: Adverse events were recorded on the Case Report Form from the time the participant had taken at least 1 dose of palbociclib through the participant's last visit.Population: All participants who received at least 1 dose of study medication were included in the safety analyses and listings.
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. Any events occurring following start of treatment or increasing in severity are counted as treatment emergent. Relatedness to palbociclib is assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
2 participant
|
0 participant
|
2 participant
|
1 participant
|
SECONDARY outcome
Timeframe: The active reporting period for serious adverse events began from the time that the participant provided informed consent through and including 28 calendar days after the last administration of palbociclib.Population: All participants who received at least 1 dose of study medication were included in the safety analyses and listings.
A serious adverse event is any untoward medical occurrence at any dose that resulted in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; or results in congenital anomaly/birth defect. Any events occurring following start of treatment or increasing in severity are counted as treatment emergent. Relatedness to palbociclib is assessed by the investigator (Yes/No).
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Serious Adverse Events
|
0 participant
|
0 participant
|
1 participant
|
0 participant
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, inclusive of baseline values.Population: All participants who received at least 1 dose of study medication were included in the safety analyses and listings.
Laboratory tests included tests that were performed under the categories of hematology, chemistry, urinalysis, other, and additional tests needed for Hy's law.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
|
6 participants
|
6 participants
|
5 participants
|
7 participants
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4.Population: All participants who received at least 1 dose of study medication were included in the safety analyses and listings.
A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The limited or abbreviated physical examination was focused on general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Number of Participants With Physical Examination Test Abnormalities (Change From Prior Visit)
|
0 participant
|
0 participant
|
2 participant
|
0 participant
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, not including baseline values.Population: All participants who received at least 1 dose of study medication were included in the safety analyses and listings.
The number of participants with post baseline vital signs values meeting the following criteria was reported: A. absolute value of supine systolic blood pressure less than (\<) 90 mmHg; B. absolute value of diastolic blood pressure \<50 mmHg; C. absolute value of supine pulse rate \<40 bmp; D. absolute value of supine pulse rate larger than (\>) 120 bmp; E. maximum increase from baseline in supine systolic blood pressure larger than and equal to (\>=) 30 mmHg; F. maximum increase from baseline in supine diastolic blood pressure \>=20 mmHg; G. maximum decrease from baseline in supine systolic blood pressure \>=30 mmHg; and H. maximum decrease from baseline in supine diastolic blood pressure \>=20 mmHg.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Number of Participants With Post Baseline Vital Signs Values Meeting Categorical Summarization Criteria
criterion A
|
0 participant
|
1 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Post Baseline Vital Signs Values Meeting Categorical Summarization Criteria
criterion B
|
0 participant
|
0 participant
|
0 participant
|
2 participant
|
|
Number of Participants With Post Baseline Vital Signs Values Meeting Categorical Summarization Criteria
criterion C
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Post Baseline Vital Signs Values Meeting Categorical Summarization Criteria
criterion D
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Post Baseline Vital Signs Values Meeting Categorical Summarization Criteria
criterion E
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Post Baseline Vital Signs Values Meeting Categorical Summarization Criteria
criterion F
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Post Baseline Vital Signs Values Meeting Categorical Summarization Criteria
criterion G
|
0 participant
|
0 participant
|
1 participant
|
1 participant
|
|
Number of Participants With Post Baseline Vital Signs Values Meeting Categorical Summarization Criteria
criterion H
|
0 participant
|
0 participant
|
0 participant
|
1 participant
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, not including baseline values.Population: All participants who received at least 1 dose of study medication were included in the safety analyses and listings. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.
Maximum absolute values of post baseline electrocardiogram were summarized for PR interval, QRS complex, QT interval, QTcB (QT interval calculated using Bazett's correction factor), and QTcF (QT interval calculated using Fridericia's correction factor). The number of participants with maximum absolute values of post baseline electrocardiogram meeting the following criteria was reported: (1) PR interval \>=300 msec; (2) QRS complex \>=140 msec; (3) QT interval 450 to \<480 msec; (4) QT interval 480 to \<500 msec; (5) QT interval \>= 500 msec; (6) QTcB 450 to \<480 msec; (7) QTcB 480 to \<500 msec; (8) QTcB \>= 500 msec; (9) QTcF 450 to \<480 msec; (10) QTcF 480 to \<500 msec; and (11) QTcF \>=500 msec. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)
PR interval >=300 msec
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)
QRS complex >=140 msec
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)
QT interval 450 to <480 msec
|
0 participant
|
1 participant
|
1 participant
|
4 participant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)
QT interval 480 to <500 msec
|
0 participant
|
2 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)
QT interval >= 500 msec
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)
QTcB 450 to <480 msec
|
0 participant
|
1 participant
|
2 participant
|
2 participant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)
QTcB 480 to <500 msec
|
0 participant
|
0 participant
|
0 participant
|
3 participant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)
QTcB >= 500 msec
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)
QTcF 450 to <480 msec
|
0 participant
|
1 participant
|
0 participant
|
5 participant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)
QTcF 480 to <500 msec
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Absolute Values)
QTcF >=500 msec
|
0 participant
|
0 participant
|
0 participant
|
0 participant
|
SECONDARY outcome
Timeframe: Baseline up to Day 6 for Cohort 1 and to Day 9 for Cohorts 2, 3, and 4, not including baseline values.Population: All participants who received at least 1 dose of study medication were included in the safety analyses and listings. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.
Maximum increases from baseline for post baseline electrocardiogram values were summarized for PR interval, QRS complex, QT interval, QTcB (QT interval calculated using Bazett's correction factor), and QTcF (QT interval calculated using Fridericia's correction factor). The number of participants with maximum increase from baseline for post baseline electrocardiogram values meeting the following criteria was reported: (1) percent change of PR interval \>=25/50%; (2) percent change of QRS complex \>=50%; (3) QT interval 30 to \<60 msec; (4) QT interval \>= 60 msec; (5) QTcB 30 to \<60 msec; (6) QTcB \>= 60 msec; (7) QTcF 30 to \<60 msec; and (8) QTcF \>= 60 msec. Seven (7) participants in each cohort were evaluated for electrocardiogram tests except that 6 participants in the moderate hepatic impairment cohort (Cohort 3) were evaluated for PR interval.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Increase From Baseline)
percent change of PR interval >=25/50%
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Increase From Baseline)
percent change of QRS complex >=50%
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Increase From Baseline)
QT interval 30 to <60 msec
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
2 paticipant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Increase From Baseline)
QT interval >= 60 msec
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Increase From Baseline)
QTcB 30 to <60 msec
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
1 paticipant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Increase From Baseline)
QTcB >= 60 msec
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
1 paticipant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Increase From Baseline)
QTcF 30 to <60 msec
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
|
Number of Participants With Post Baseline Electrocardiogram Values Meeting Categorical Summarization Criteria (Maximum Increase From Baseline)
QTcF >= 60 msec
|
0 paticipant
|
0 paticipant
|
0 paticipant
|
1 paticipant
|
SECONDARY outcome
Timeframe: From screening through and including Day 6 for Cohort 1, and from screening through and including Day 9 for Cohorts 2, 3, and 4.Population: All participants who received at least 1 dose of study medication were included in the safety analyses and listings.
Treatments taken after the first dose of study treatment were documented as concomitant treatments.
Outcome measures
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 Participants
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 Participants
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 Participants
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 Participants
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Number of Participants With Concomitant Medications
|
0 participant
|
3 participant
|
7 participant
|
7 participant
|
Adverse Events
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 participants at risk
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 participants at risk
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 participants at risk
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 participants at risk
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
14.3%
1/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
Other adverse events
| Measure |
Palbociclib 75 mg (Normal Hepatic Function, Cohort 1)
n=7 participants at risk
Participants with normal hepatic function were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Mild Hepatic Impairment, Cohort 2)
n=7 participants at risk
Participants with Child-Pugh scores of 5 to 6 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Moderate Hepatic Impairment, Cohort 3)
n=7 participants at risk
Participants with Child-Pugh scores of 7 to 9 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
Palbociclib 75 mg (Severe Hepatic Impairment, Cohort 4)
n=7 participants at risk
Participants with Child-Pugh scores of 10 to 15 points were enrolled in this cohort. Participants received single oral dose of palbociclib 75 mg approximately 10 minutes after completion of the moderate fat standard calorie breakfast, with approximately 240 mL of ambient temperature water.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
|
General disorders
Infusion site bruising
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
14.3%
1/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
|
General disorders
Infusion site reaction
|
14.3%
1/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
|
Nervous system disorders
Headache
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
14.3%
1/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
14.3%
1/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
|
Nervous system disorders
Radial nerve compression
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
14.3%
1/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
14.3%
1/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
0.00%
0/7 • For adverse event, from the time participant took at least 1 dose of palbociclib through the last visit. For serious adverse event, from the participant provided informed consent through 28 calendar days post last administration of palbociclib.
The listing of Other Adverse Events does not include events already captured in the Serious Adverse Event listing. An adverse event of diarrhea was reported in the moderate hepatic impairment cohort after database lock and release. It was therefore not recorded in the clinical database, but was added here for completeness and transparency.
|
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