Trial Outcomes & Findings for A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers (NCT NCT01984229)
NCT ID: NCT01984229
Last Updated: 2016-10-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 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 period
Results posted on
2016-10-11
Participant Flow
Participant milestones
| Measure |
Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole
There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40 milligrams (mg) single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg twice daily (BID) oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
|
Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole
There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
|
|---|---|---|
|
Period 1
STARTED
|
6
|
17
|
|
Period 1
COMPLETED
|
6
|
17
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
6
|
17
|
|
Period 2
COMPLETED
|
6
|
17
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
|
Period 3
STARTED
|
6
|
17
|
|
Period 3
COMPLETED
|
6
|
17
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
|
Safety Follow-up Period
STARTED
|
6
|
17
|
|
Safety Follow-up Period
COMPLETED
|
4
|
16
|
|
Safety Follow-up Period
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole
There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40 milligrams (mg) single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg twice daily (BID) oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
|
Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole
There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
|
|---|---|---|
|
Safety Follow-up Period
Adverse Event
|
1
|
1
|
|
Safety Follow-up Period
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole
n=6 Participants
There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
|
Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole
n=17 Participants
There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.8 years
STANDARD_DEVIATION 8.50 • n=5 Participants
|
38.5 years
STANDARD_DEVIATION 8.40 • n=7 Participants
|
38.3 years
STANDARD_DEVIATION 8.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 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 periodPopulation: Pharmacokinetic (PK) Analysis Population \[Cohort A\] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Alectinib: Cohort A
|
27.6 nanograms per milliliter (ng/mL)
Standard Deviation 6.61
|
35.0 nanograms per milliliter (ng/mL)
Standard Deviation 10.8
|
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 periodPopulation: PK Analysis Population \[Cohort A\]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Alectinib: Cohort A
|
634 hours*nanograms per milliliter (h*ng/mL)
Standard Deviation 133
|
1030 hours*nanograms per milliliter (h*ng/mL)
Standard Deviation 270
|
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 period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosingPopulation: PK Analysis Population \[Cohort B\] consisted of all participants who received both scheduled doses of Alectinib, and provided adequate PK assessments.
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Cmax of Alectinib: Cohort B
|
147 ng/mL
Standard Deviation 39.3
|
171 ng/mL
Standard Deviation 38.2
|
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 period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosingPopulation: PK Analysis Population \[Cohort B\]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
AUClast of Alectinib: Cohort B
|
2770 h*ng/mL
Standard Deviation 545
|
4910 h*ng/mL
Standard Deviation 893
|
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 period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosingPopulation: PK Analysis Population \[Cohort B\]
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 |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of RO5424802: Cohort B
|
2850 h*ng/mL
Standard Deviation 549
|
4990 h*ng/mL
Standard Deviation 888
|
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 \[Cohort A\]
RO5468924 is M4 metabolite of Alectinib.
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Cmax of RO5468924: Cohort A
|
6.52 ng/mL
Standard Deviation 1.59
|
2.54 ng/mL
Standard Deviation 0.296
|
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 \[Cohort A\]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of Alectinib.
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
AUClast of RO5468924: Cohort A
|
138 h*ng/mL
Standard Deviation 36.8
|
65.1 h*ng/mL
Standard Deviation 20.4
|
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 periodPopulation: PK Analysis Population \[Cohort A\]. Here, number of participants analyzed = participants who were evaluable for this outcome.
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 |
Cohort A: Alectinib (Period 1)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=3 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
AUC0-inf of RO5468924: Cohort A
|
201 h*ng/mL
Standard Deviation 35.9
|
256 h*ng/mL
Standard Deviation 94.5
|
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 period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosingPopulation: PK Analysis Population \[Cohort B\]
RO5468924 is M4 metabolite of Alectinib.
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Cmax of RO5468924: Cohort B
|
59.6 ng/mL
Standard Deviation 27.1
|
15.5 ng/mL
Standard Deviation 4.0
|
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 period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosingPopulation: PK Analysis Population \[Cohort B\]
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast). RO5468924 is M4 metabolite of Alectinib.
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
AUClast of RO5468924: Cohort B
|
1460 h*ng/mL
Standard Deviation 562
|
910 h*ng/mL
Standard Deviation 211
|
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 period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosingPopulation: PK Analysis Population \[Cohort B\]
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 |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
AUC0-inf of RO5468924: Cohort B
|
1550 h*ng/mL
Standard Deviation 569
|
1110 h*ng/mL
Standard Deviation 284
|
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 \[Cohort A\]
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alectinib: Cohort A
|
8.15 hours
Interval 6.0 to 12.0
|
8.00 hours
Interval 4.0 to 11.9
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment periodPopulation: PK Analysis Population \[Cohort B\]
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Tmax of Alectinib: Cohort B
|
8.00 hours
Interval 6.0 to 12.0
|
8.00 hours
Interval 6.0 to 11.9
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment periodPopulation: PK analysis population \[Cohort A\]
RO5468924 is M4 metabolite of Alectinib.
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Tmax of RO5468924: Cohort A
|
12.0 hours
Interval 6.03 to 12.0
|
11.9 hours
Interval 6.0 to 11.9
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours after dosing in each treatment period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosingPopulation: PK Analysis Population \[Cohort B\]
RO5468924 is M4 metabolite of Alectinib.
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Tmax of RO5468924: Cohort B
|
12.0 hours
Interval 6.0 to 12.0
|
11.9 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 period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosingPopulation: PK Analysis Population \[Cohort B\]
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 |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Metabolite/Parent Ratio for AUC0-inf: Cohort B
|
0.541 ratio
Standard Deviation 0.12
|
0.232 ratio
Standard Deviation 0.02
|
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 period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosingPopulation: PK Analysis Population \[Cohort B\]
RO5468924 is M4 metabolite of Alectinib. The ratio is molecular weight adjusted.
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Metabolite/Parent Ratio for Cmax: Cohort B
|
0.393 ratio
Standard Deviation 0.10
|
0.0953 ratio
Standard Deviation 0.01
|
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 \[Cohort A\]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
Terminal Half-life (t1/2) of Alectinib: Cohort A
|
19.6 hours
Standard Deviation 2.37
|
26.9 hours
Standard Deviation 3.22
|
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 period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosingPopulation: PK Analysis Population \[Cohort B\]
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Outcome measures
| Measure |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
t1/2 of Alectinib: Cohort B
|
18.4 hours
Standard Deviation 4.36
|
24.8 hours
Standard Deviation 5.08
|
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 periodPopulation: PK analysis population \[Cohort A\]. Here, number of participants analyzed = participants who were evaluable for this outcome.
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 |
Cohort A: Alectinib (Period 1)
n=5 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=3 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
t1/2 of RO5468924: Cohort A
|
23.9 hours
Standard Deviation 9.92
|
79.6 hours
Standard Deviation 47.2
|
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 period, and additional samples were collected in Period 3 at 120, 144, 168, 192, and 216 hours after dosingPopulation: PK Analysis Population \[Cohort B\]
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 |
Cohort A: Alectinib (Period 1)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=16 Participants
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|
|
t1/2 of RO5468924: Cohort B
|
25.3 hours
Standard Deviation 4.12
|
69.6 hours
Standard Deviation 22.7
|
Adverse Events
Cohort A: Alectinib (Period 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort A: Posaconazole (Period 2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A: Alectinib + Posaconazole (Period 3)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B: Alectinib (Period 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B: Posaconazole (Period 2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort B: Alectinib + Posaconazole (Period 3)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A: Alectinib (Period 1)
n=6 participants at risk
Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
|
Cohort A: Posaconazole (Period 2)
n=6 participants at risk
Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
|
Cohort A: Alectinib + Posaconazole (Period 3)
n=5 participants at risk
Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
Cohort B: Alectinib (Period 1)
n=17 participants at risk
Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
|
Cohort B: Posaconazole (Period 2)
n=17 participants at risk
Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
|
Cohort B: Alectinib + Posaconazole (Period 3)
n=17 participants at risk
Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
11.8%
2/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
11.8%
2/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
General disorders
Nodule
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
16.7%
1/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
20.0%
1/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
16.7%
1/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
16.7%
1/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Investigations
Blood creatine phosphokinase increase
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
20.0%
1/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
16.7%
1/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
33.3%
2/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
16.7%
1/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
20.0%
1/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/6 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/5 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
0.00%
0/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
5.9%
1/17 • Day 1 up to 10 to 14 days after last dose of posaconazole (Cohort A: maximum up to 28 to 32 days; Cohort B: maximum up to 31 to 35 days)
Safety Analysis Set. Only 5 participants were evaluable for adverse events in Cohort A: Alectinib + Posaconazole (Period 3) arm.
|
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