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Trial Outcomes & Findings for Safety of Single Rising Doses and Relative Bioavailability of BI 691751 (NCT NCT01843972)

NCT ID: NCT01843972

Last Updated: 2016-06-27

Results Overview

AUC0-72h (area under the concentration-time curve of the analyte of BI 691751 in plasma over the time interval from 0 to 72 h) (part II). PPS-BA included all subjects in the TS who were randomised to the BA part, who provided at least one observation for at least one primary endpoint, had no important protocol violations relevant for the statistical evaluation of BA and did not experience emesis at or before twice the median tmax.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

81 participants

Primary outcome timeframe

1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration

Results posted on

2016-06-27

Participant Flow

Participant milestones

Participant milestones
Measure
Placebo (Part I)
placebo solution Placebo: placebo solution
BI 691751 Dose 1 (Part I)
single dose given as oral solution BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)
BI 691751 Dose 2 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)
BI 691751 Dose 3 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 3 (5 mg powder)
BI 691751 Dose 4 (Part I)
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Tablet (Part II)
single dose given as 1 tablet BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
Overall Study
STARTED
13
6
5
6
6
6
5
5
17
12
Overall Study
COMPLETED
13
6
5
6
5
6
5
5
17
12
Overall Study
NOT COMPLETED
0
0
0
0
1
0
0
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Placebo (Part I)
placebo solution Placebo: placebo solution
BI 691751 Dose 1 (Part I)
single dose given as oral solution BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)
BI 691751 Dose 2 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)
BI 691751 Dose 3 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 3 (5 mg powder)
BI 691751 Dose 4 (Part I)
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Tablet (Part II)
single dose given as 1 tablet BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
Overall Study
Withdrawal by Subject
0
0
0
0
1
0
0
0
0
0

Baseline Characteristics

Safety of Single Rising Doses and Relative Bioavailability of BI 691751

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo (Part I)
n=13 Participants
placebo solution Placebo: placebo solution
BI 691751dose 1 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)
BI 691751 Dose 2 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)
BI 691751 Dose 3 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 3 (5 mg powder)
BI 691751 Dose 4 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Tablet (Part II)
n=17 Participants
single dose given as 1 tablet BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=12 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
Total
n=81 Participants
Total of all reporting groups
Age, Continuous
28.3 years
STANDARD_DEVIATION 8.2 • n=93 Participants
31.2 years
STANDARD_DEVIATION 8.0 • n=4 Participants
32.0 years
STANDARD_DEVIATION 8.4 • n=27 Participants
34.5 years
STANDARD_DEVIATION 6.8 • n=483 Participants
26.5 years
STANDARD_DEVIATION 5.2 • n=36 Participants
37.5 years
STANDARD_DEVIATION 6.0 • n=10 Participants
29.2 years
STANDARD_DEVIATION 2.6 • n=115 Participants
30.2 years
STANDARD_DEVIATION 8.0 • n=40 Participants
32.2 years
STANDARD_DEVIATION 9.3 • n=8 Participants
35.8 years
STANDARD_DEVIATION 10.2 • n=62 Participants
31.8 years
STANDARD_DEVIATION 8.3 • n=95 Participants
Sex: Female, Male
Female
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=40 Participants
0 Participants
n=8 Participants
0 Participants
n=62 Participants
0 Participants
n=95 Participants
Sex: Female, Male
Male
13 Participants
n=93 Participants
6 Participants
n=4 Participants
5 Participants
n=27 Participants
6 Participants
n=483 Participants
6 Participants
n=36 Participants
6 Participants
n=10 Participants
5 Participants
n=115 Participants
5 Participants
n=40 Participants
17 Participants
n=8 Participants
12 Participants
n=62 Participants
81 Participants
n=95 Participants

PRIMARY outcome

Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h and 72h after drug administration

Population: Per protocol set for evaluation of bioavailability (PPS-BA). Only subjects with calculable PK parameter were analysed.

AUC0-72h (area under the concentration-time curve of the analyte of BI 691751 in plasma over the time interval from 0 to 72 h) (part II). PPS-BA included all subjects in the TS who were randomised to the BA part, who provided at least one observation for at least one primary endpoint, had no important protocol violations relevant for the statistical evaluation of BA and did not experience emesis at or before twice the median tmax.

Outcome measures

Outcome measures
Measure
BI 691751 Tablet Extensive Metabolizers (Part II)
n=12 Participants
single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Tablet Poor Metabolizers (Part II)
n=5 Participants
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=7 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Dose 4 (Part I)
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Solution (Part II); Extensive Metabolizers
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Tablet Poor Metabolizers (Part II)
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
AUC0-72h (Part II)
2740 nmol*h/L
Geometric Coefficient of Variation 26.1
3050 nmol*h/L
Geometric Coefficient of Variation 20.5
2800 nmol*h/L
Geometric Coefficient of Variation 22.2
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: 1 hour (h) before drug administration and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug administration

Population: PPS-BA. Only subjects with calculable PK parameter were analysed.

Cmax (maximum measured concentration of the analyte of BI 691751 in plasma) (part II)

Outcome measures

Outcome measures
Measure
BI 691751 Tablet Extensive Metabolizers (Part II)
n=12 Participants
single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Tablet Poor Metabolizers (Part II)
n=5 Participants
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=7 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Dose 4 (Part I)
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Solution (Part II); Extensive Metabolizers
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Tablet Poor Metabolizers (Part II)
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
Cmax (Part II)
223 nmol/L
Geometric Coefficient of Variation 33.6
207 nmol/L
Geometric Coefficient of Variation 31.3
220 nmol/L
Geometric Coefficient of Variation 14.4
—
—
—
—
—
—
—

PRIMARY outcome

Timeframe: Part I: 'Day1 to Day21 for Dose 1, 2,3 &4 and Day1 to Day45 for Dose group 5,6 & 7

Population: Treated Set (TS): all subjects who were documented to have taken at least 1 dose of study medication.

Frequency of subjects with drug-related Adverse Events (AEs) (Part I)

Outcome measures

Outcome measures
Measure
BI 691751 Tablet Extensive Metabolizers (Part II)
n=13 Participants
single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Tablet Poor Metabolizers (Part II)
n=6 Participants
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=5 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Dose 4 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Solution (Part II); Extensive Metabolizers
n=5 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Tablet Poor Metabolizers (Part II)
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
Frequency of Subjects With Drug-related Adverse Events (Part I)
1 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
—
—

SECONDARY outcome

Timeframe: for dose 1 & 2: up to 168h, for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h

Population: Per protocol set for evaluation of dose proportionality (PPS-DP): This subject set includes all subjects of the TS who were randomised to active treatment in the single rising dose part or BA part, and had no important PVs relevant for the statistical evaluation of dose proportionality. Only subjects with calculable PK parameter were analysed.

Cmax (maximum measured concentration of BI 691751 in plasma) (part I) Time frame: Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin

Outcome measures

Outcome measures
Measure
BI 691751 Tablet Extensive Metabolizers (Part II)
n=4 Participants
single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Tablet Poor Metabolizers (Part II)
n=5 Participants
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=6 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Dose 4 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Solution (Part II); Extensive Metabolizers
n=7 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Tablet Poor Metabolizers (Part II)
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
Cmax (Part I)
3.45 nmol/L
Geometric Coefficient of Variation 15.5
18.3 nmol/L
Geometric Coefficient of Variation 39.3
88.9 nmol/L
Geometric Coefficient of Variation 59.1
729 nmol/L
Geometric Coefficient of Variation 21.5
1320 nmol/L
Geometric Coefficient of Variation 31.5
3320 nmol/L
Geometric Coefficient of Variation 46.7
4180 nmol/L
Geometric Coefficient of Variation 22.2
220 nmol/L
Geometric Coefficient of Variation 14.4
—
—

SECONDARY outcome

Timeframe: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h

Population: PPS-DP. Only subjects with calculable PK parameter were analysed.

AUC0-infinity (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 extrapolated to infinity) (part I) Time frame: Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin

Outcome measures

Outcome measures
Measure
BI 691751 Tablet Extensive Metabolizers (Part II)
single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Tablet Poor Metabolizers (Part II)
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=6 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Dose 4 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Solution (Part II); Extensive Metabolizers
n=7 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Tablet Poor Metabolizers (Part II)
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
AUC0-infinity (Part I)
—
—
1140 nmol*h/L
Geometric Coefficient of Variation 34.5
7250 nmol*h/L
Geometric Coefficient of Variation 15.9
11900 nmol*h/L
Geometric Coefficient of Variation 27.2
24500 nmol*h/L
Geometric Coefficient of Variation 20.0
41000 nmol*h/L
Geometric Coefficient of Variation 26.9
3630 nmol*h/L
Geometric Coefficient of Variation 28.5
—
—

SECONDARY outcome

Timeframe: Part 1: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 7: up to 720h; Part 2: up to 720h

Population: PPS-DP for part I and PPS-BA for part II. Only subjects with calculable PK parameter were analysed.

AUC0-tz (area under the concentration-time curve of BI 691751 in plasma over the time interval from 0 up to the last quantifiable data point) (Part I and Part II) Time frame: Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin

Outcome measures

Outcome measures
Measure
BI 691751 Tablet Extensive Metabolizers (Part II)
single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Tablet Poor Metabolizers (Part II)
n=5 Participants
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=6 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Dose 4 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Solution (Part II); Extensive Metabolizers
n=12 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Tablet Poor Metabolizers (Part II)
n=5 Participants
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=7 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
AUC0-tz
—
29.5 nmol*h/L
Geometric Coefficient of Variation 18.4
791 nmol*h/L
Geometric Coefficient of Variation 45.4
6310 nmol*h/L
Geometric Coefficient of Variation 15.4
11400 nmol*h/L
Geometric Coefficient of Variation 28.3
24100 nmol*h/L
Geometric Coefficient of Variation 21.1
40500 nmol*h/L
Geometric Coefficient of Variation 27.2
3150 nmol*h/L
Geometric Coefficient of Variation 32.0
3460 nmol*h/L
Geometric Coefficient of Variation 17.4
3300 nmol*h/L
Geometric Coefficient of Variation 28.5

SECONDARY outcome

Timeframe: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h

Population: Pharmacokinetic (PK) set (PKS) which includes all subjects of the treated set were were randomised to active treatment in the single rising dose part of bioavailability part, and had no important protocol violations relevant for the statistical evaluation of further PK parameters. Only subjects with calculable PK parameter were analysed.

t1/2 (terminal half-life of the analyte of BI 691751 in plasma) (part I) Time frame: Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin

Outcome measures

Outcome measures
Measure
BI 691751 Tablet Extensive Metabolizers (Part II)
single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Tablet Poor Metabolizers (Part II)
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=6 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Dose 4 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Solution (Part II); Extensive Metabolizers
n=7 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Tablet Poor Metabolizers (Part II)
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
t1/2 (Part I)
—
—
65.4 h
Geometric Coefficient of Variation 37.8
97.4 h
Geometric Coefficient of Variation 63.3
74.9 h
Geometric Coefficient of Variation 49.2
57.2 h
Geometric Coefficient of Variation 34.3
78.3 h
Geometric Coefficient of Variation 16.9
59.4 h
Geometric Coefficient of Variation 57.1
—
—

SECONDARY outcome

Timeframe: for dose 1 & 2: up to 168 hours (h), for dose 3 & 4: up to 240h, for dose 5 to 8: up to 720h

Population: PKS

tmax (time from dosing to maximum measured concentration of BI 691751) (part I) Time frame: Dose 1 and 2: 1 hour (h) before drug administration (admin) and 20 minutes (min), 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h and 168h after drug admin Dose 3 and 4: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h (dose group 4 only), 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h and 240h after drug admin Dose 5 to 7: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 60h, 72h, 96h, 120h, 144h, 192h, 240h, 336h, 432h, 528h, 624h and 720h after drug admin Dose 8: 1h before drug admin and 20 min, 40min, 1h, 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 144h, 216h, 384h, 552h and 720h after drug admin

Outcome measures

Outcome measures
Measure
BI 691751 Tablet Extensive Metabolizers (Part II)
n=4 Participants
single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Tablet Poor Metabolizers (Part II)
n=5 Participants
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=6 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Dose 4 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
n=6 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
n=5 Participants
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Solution (Part II); Extensive Metabolizers
n=7 Participants
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
BI 691751 Tablet Poor Metabolizers (Part II)
single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
Tmax (Part I)
0.667 h
Interval 0.333 to 0.667
0.667 h
Interval 0.35 to 0.667
0.842 h
Interval 0.333 to 2.02
0.500 h
Interval 0.333 to 0.667
0.350 h
Interval 0.333 to 0.667
0.667 h
Interval 0.333 to 1.5
0.667 h
Interval 0.333 to 1.02
0.667 h
Interval 0.333 to 1.5
—
—

Adverse Events

Placebo (Part I)

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

BI 691751 Dose 1 (Part I)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

BI 691751 Dose 2 (Part I)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

BI 691751 Dose 3 (Part I)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

BI 691751 Dose 4 (Part I)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

BI 691751 Dose 5 (Part I)

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

BI 691751 Dose 6 (Part I)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

BI 691751 Dose 7 (Part I)

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

BI 691751 Tablet (Part II)

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

BI 691751 Solution (Part II); Extensive Metabolizers

Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Placebo (Part I)
n=13 participants at risk
placebo solution Placebo: placebo solution
BI 691751 Dose 1 (Part I)
n=6 participants at risk
single dose given as oral solution BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)
BI 691751 Dose 2 (Part I)
n=5 participants at risk
single dose given as oral solution BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)
BI 691751 Dose 3 (Part I)
n=6 participants at risk
single dose given as oral solution BI 691751: oral solution BI 691751, dose 3 (5 mg powder)
BI 691751 Dose 4 (Part I)
n=6 participants at risk
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
n=6 participants at risk
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
n=5 participants at risk
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
n=5 participants at risk
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Tablet (Part II)
n=17 participants at risk
single dose given as 1 tablet BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=12 participants at risk
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
Injury, poisoning and procedural complications
Contusion
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
8.3%
1/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.

Other adverse events

Other adverse events
Measure
Placebo (Part I)
n=13 participants at risk
placebo solution Placebo: placebo solution
BI 691751 Dose 1 (Part I)
n=6 participants at risk
single dose given as oral solution BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)
BI 691751 Dose 2 (Part I)
n=5 participants at risk
single dose given as oral solution BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)
BI 691751 Dose 3 (Part I)
n=6 participants at risk
single dose given as oral solution BI 691751: oral solution BI 691751, dose 3 (5 mg powder)
BI 691751 Dose 4 (Part I)
n=6 participants at risk
single dose given as oral solution BI 691751: oral solution BI 69175, dose 4 (15 mg powder)
BI 691751 Dose 5 (Part I)
n=6 participants at risk
single dose given as oral solution BI 691751: oral solution BI 691751, dose 5 (30 mg powder)
BI 691751 Dose 6 (Part I)
n=5 participants at risk
single dose given as oral solution BI 691751: oral solution BI 691751, dose 6 (60 mg powder)
BI 691751 Dose 7 (Part I)
n=5 participants at risk
single dose given as oral solution BI 691751: oral solution BI 691751, dose 7 (90 mg powder)
BI 691751 Tablet (Part II)
n=17 participants at risk
single dose given as 1 tablet BI 691751: 1 tablet (10 mg)
BI 691751 Solution (Part II); Extensive Metabolizers
n=12 participants at risk
single dose given as oral solution BI 691751: oral solution (10 mg) 5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses.
Infections and infestations
Influenza
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
8.3%
1/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Infections and infestations
Nasopharyngitis
15.4%
2/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
16.7%
1/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
16.7%
1/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
16.7%
1/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
40.0%
2/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Nervous system disorders
Headache
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
20.0%
1/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
16.7%
1/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
20.0%
1/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
40.0%
2/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Nervous system disorders
Syncope
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
16.7%
1/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Eye disorders
Eye irritation
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
16.7%
1/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Cardiac disorders
Tachycardia
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
20.0%
1/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Vascular disorders
Haematoma
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
5.9%
1/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Vascular disorders
Hot flush
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
20.0%
1/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
20.0%
1/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
5.9%
1/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Respiratory, thoracic and mediastinal disorders
Epistaxis
7.7%
1/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
16.7%
1/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
20.0%
1/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
8.3%
1/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Gastrointestinal disorders
Aphthous stomatitis
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
8.3%
1/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Gastrointestinal disorders
Diarrhoea
7.7%
1/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Gastrointestinal disorders
Flatulence
7.7%
1/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Gastrointestinal disorders
Nausea
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
5.9%
1/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Gastrointestinal disorders
Toothache
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
16.7%
1/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Gastrointestinal disorders
Vomiting
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
5.9%
1/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Skin and subcutaneous tissue disorders
Blister
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
5.9%
1/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
8.3%
1/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
20.0%
1/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
20.0%
1/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
7.7%
1/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
20.0%
1/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
16.7%
1/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Injury, poisoning and procedural complications
Arthropod sting
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
5.9%
1/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Injury, poisoning and procedural complications
Laceration
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
5.9%
1/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Injury, poisoning and procedural complications
Muscle strain
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
5.9%
1/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Injury, poisoning and procedural complications
Road traffic accident
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
8.3%
1/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
Injury, poisoning and procedural complications
Thermal burn
0.00%
0/13 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/6 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
20.0%
1/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/5 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/17 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.
0.00%
0/12 • Day1 to Day21 for Dose group 1, 2,3 & 4 and Day1 to Day45 for Dose group 5,6 & 7. Part II: Day1 to Day 45.
Subjects randomised to 0.5 mg sol. or 1.5 mg sol. were planned by the CTP to be observed for 8 to 21 days, subjects randomised to 5 mg sol. or 15 mg sol. for 11 to 21 days, and subjects randomised to 10 mg sol., 10 mg tab., 30 mg sol., 60 mg sol., or 90 mg sol. for 31 to 45 days after treatment.

Additional Information

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