Trial Outcomes & Findings for A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers. (NCT NCT02023125)
NCT ID: NCT02023125
Last Updated: 2016-10-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment arm
Results posted on
2016-10-07
Participant Flow
Participant milestones
| Measure |
Group 1: Treatment A First, Then Treatment B
Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600 milligrams (mg) oral dose of alectinib was administered. Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Each period was separated by at least 10 days.
|
Group 1: Treatment B First, Then Treatment A
Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered. Each period was separated by at least 10 days.
|
Group 2: Alectinib Alone, Alectinib + Esomeprazole
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
|
|---|---|---|---|
|
Period 1
STARTED
|
9
|
9
|
24
|
|
Period 1
COMPLETED
|
9
|
9
|
24
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout Period
STARTED
|
9
|
9
|
24
|
|
Washout Period
COMPLETED
|
9
|
9
|
24
|
|
Washout Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Period 2
STARTED
|
9
|
9
|
24
|
|
Period 2
COMPLETED
|
9
|
9
|
24
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study Investigating the Effect of Food and Esomeprazole on the Single Oral Dose Pharmacokinetics of Alectinib (RO5424802) in Healthy Volunteers.
Baseline characteristics by cohort
| Measure |
Group 1 (Treatment Sequence AB or BA)
n=18 Participants
Participants in Group 1 were randomly assigned to a two period treatment sequence (AB or BA) in which they received a single, oral dose of 600 mg of alectinib per period separated by at least 10 days. Each participant received single, oral doses alectinib given under fasted conditions (Treatment A) or following the ingestion of a high fat, high calorie meal (Treatment B) as determined by their assigned sequence.
|
Group 2: Alectinib Alone, Alectinib + Esomeprazole
n=24 Participants
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.3 years
STANDARD_DEVIATION 8.50 • n=5 Participants
|
35.4 years
STANDARD_DEVIATION 8.30 • n=7 Participants
|
35.4 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: Pharmacokinetic (PK) Analysis Population \[Group 1\] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Alectinib: Group 1
|
103 nanograms per milliliter (ng/mL)
Standard Deviation 41.1
|
270 nanograms per milliliter (ng/mL)
Standard Deviation 86.4
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Cmax of Alectinib: Group 2
|
169 ng/mL
Standard Deviation 47.3
|
196 ng/mL
Standard Deviation 54.7
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: PK Analysis Population \[Group 1\]
AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of Alectinib: Group 1
|
1900 hours*nanograms per milliliter (h*ng/mL)
Standard Deviation 665
|
5480 hours*nanograms per milliliter (h*ng/mL)
Standard Deviation 1800
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
AUC0-inf of Alectinib: Group 2
|
3180 h*ng/mL
Standard Deviation 876
|
3940 h*ng/mL
Standard Deviation 1310
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: PK Analysis Population \[Group 1\]
RO5468924 is M4 metabolite of alectinib.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Cmax of RO5468924: Group 1
|
37.5 ng/mL
Standard Deviation 20.7
|
126 ng/mL
Standard Deviation 31.9
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
RO5468924 is M4 metabolite of alectinib.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Cmax of RO5468924: Group 2
|
72.1 ng/mL
Standard Deviation 28.8
|
72.1 ng/mL
Standard Deviation 26.4
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: PK Analysis Population \[Group 1\]
AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
AUC0-inf of RO5468924: Group 1
|
1140 h*ng/mL
Standard Deviation 497
|
3480 h*ng/mL
Standard Deviation 758
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
AUC0-inf of RO5468924: Group 2
|
1860 h*ng/mL
Standard Deviation 639
|
2050 h*ng/mL
Standard Deviation 713
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: PK Analysis Population \[Group 1\]
AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Metabolite/Parent Ratio for AUC0-inf: Group 1
|
0.610 ratio
Standard Deviation 0.07
|
0.686 ratio
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
AUC (0-inf) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0 - t) plus AUC (t - inf). RO5468924 is M4 metabolite of alectinib. The ratio is molecular weight adjusted.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Metabolite/Parent Ratio for AUC0-inf: Group 2
|
0.548 ratio
Standard Deviation 0.05
|
0.607 ratio
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: PK Analysis Population \[Group 1\]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Alectinib: Group 1
|
1780 h*ng/mL
Standard Deviation 648
|
5360 h*ng/mL
Standard Deviation 1750
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
AUClast of Alectinib: Group 2
|
3050 h*ng/mL
Standard Deviation 867
|
3790 h*ng/mL
Standard Deviation 1280
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: PK Analysis Population \[Group 1\]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
AUClast of RO5468924: Group 1
|
1030 h*ng/mL
Standard Deviation 491
|
3290 h*ng/mL
Standard Deviation 715
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of alectinib.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
AUClast of RO5468924: Group 2
|
1750 h*ng/mL
Standard Deviation 617
|
1920 h*ng/mL
Standard Deviation 685
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: PK Analysis Population \[Group 1\]
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib: Group 1
|
4.00 hours
Interval 2.0 to 8.0
|
8.00 hours
Interval 6.0 to 12.0
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Tmax of Alectinib: Group 2
|
6.00 hours
Interval 4.0 to 10.0
|
6.00 hours
Interval 4.0 to 10.0
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: PK Analysis Population \[Group 1\]
RO5468924 is M4 metabolite of alectinib.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Tmax of RO5468924: Group 1
|
8.00 hours
Interval 4.02 to 12.0
|
10.0 hours
Interval 6.0 to 12.0
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
RO5468924 is M4 metabolite of alectinib.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Tmax of RO5468924: Group 2
|
6.02 hours
Interval 6.0 to 12.0
|
8.00 hours
Interval 6.0 to 12.0
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: PK Analysis Population \[Group 1\]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Terminal Half-life (t1/2) of Alectinib: Group 1
|
23.4 hours
Standard Deviation 13.7
|
17.7 hours
Standard Deviation 5.12
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
t1/2 of Alectinib: Group 2
|
20.4 hours
Standard Deviation 9.33
|
20.4 hours
Standard Deviation 7.56
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment periodPopulation: PK Analysis Population \[Group 1\]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
t1/2 of RO5468924: Group 1
|
29.4 hours
Standard Deviation 7.05
|
22.7 hours
Standard Deviation 3.27
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. RO5468924 is M4 metabolite of alectinib.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
t1/2 of RO5468924: Group 2
|
25.0 hours
Standard Deviation 4.56
|
25.4 hours
Standard Deviation 5.06
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: PK Analysis Population \[Group 1\]
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Apparent Oral Clearance (CL/F) for Alectinib: Group 1
|
357 Liters per hour (L/h)
Standard Deviation 136
|
120 Liters per hour (L/h)
Standard Deviation 38.1
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
CL/F for Alectinib: Group 2
|
206 L/h
Standard Deviation 72.5
|
170 L/h
Standard Deviation 61.0
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment armPopulation: PK Analysis Population \[Group 1\]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F) for Alectinib: Group 1
|
11800 Liters
Standard Deviation 7200
|
3060 Liters
Standard Deviation 1290
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours post alectinib dose in each treatment periodPopulation: PK Analysis Population \[Group 2\]
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Vz/F is influenced by the fraction absorbed.
Outcome measures
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=24 Participants
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
|---|---|---|
|
Vz/F for Alectinib: Group 2
|
5930 Liters
Standard Deviation 2950
|
4890 Liters
Standard Deviation 2070
|
Adverse Events
Group 1: Treatment A (Fasted Treatment)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 1: Treatment B (Fed Treatment)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: Period 1 (Alectinib Alone)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Group 2: Period 2 (Esomeprazole Alone)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2: Period 2 (Alectinib + Esomeprazole)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Treatment A (Fasted Treatment)
n=18 participants at risk
Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
|
Group 1: Treatment B (Fed Treatment)
n=18 participants at risk
Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
|
Group 2: Period 1 (Alectinib Alone)
n=24 participants at risk
Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
|
Group 2: Period 2 (Esomeprazole Alone)
n=24 participants at risk
Period 2: From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast.
|
Group 2: Period 2 (Alectinib + Esomeprazole)
n=24 participants at risk
Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
8.3%
2/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Gastrointestinal disorders
Lip dry
|
11.1%
2/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
11.1%
2/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
General disorders
Influenza-like illness
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
General disorders
Application site pruritus
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
5.6%
1/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/18 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
4.2%
1/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
0.00%
0/24 • Day 1 up to 7 to 10 days after last dose of alectinib (Cohort 1: maximum up to 18 to 21 days; Cohort 2: maximum up to 23 to 26 days)
Safety Analysis Set.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER