Trial Outcomes & Findings for Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608 (NCT NCT01703858)
NCT ID: NCT01703858
Last Updated: 2017-01-20
Results Overview
Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.
Results posted on
2017-01-20
Participant Flow
An open label, randomised, single dose, 3-way cross-over study to investigate relative bioavailability and food effect on different formulations of Boehringer-Ingelheim (BI) -113608 in healthy male subjects, followed by fixed sequence periods investigating influence of pantoprazole coadministration and food effect on pharmacokinetics of BI-113608.
Participant milestones
| Measure |
A - C - B - D - E
Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
|
B - A - C - D - E
Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
|
C - B - A - D - E
Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
A - C - B - D - E
Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
|
B - A - C - D - E
Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
|
C - B - A - D - E
Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608
Baseline characteristics by cohort
| Measure |
A - C - B - D - E
n=5 Participants
Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
|
B - A - C - D - E
n=5 Participants
Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
|
C - B - A - D - E
n=5 Participants
Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.4 Years
STANDARD_DEVIATION 8.9 • n=93 Participants
|
40.8 Years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
41.8 Years
STANDARD_DEVIATION 7.9 • n=27 Participants
|
40.7 Years
STANDARD_DEVIATION 7.9 • n=483 Participants
|
|
Gender
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Gender
Male
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.Population: Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz).
Outcome measures
| Measure |
A : BI-113608
n=15 Participants
Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
|
B : BI-113608
n=15 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
|
C : BI-113608
n=15 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
|
D : BI-113608
n=15 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
|
E : BI-113608
n=14 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
|
936 nanomol (nmol)* hours (h) / Litre (L)
Geometric Coefficient of Variation 27.4
|
924 nanomol (nmol)* hours (h) / Litre (L)
Geometric Coefficient of Variation 31.2
|
648 nanomol (nmol)* hours (h) / Litre (L)
Geometric Coefficient of Variation 39.3
|
900 nanomol (nmol)* hours (h) / Litre (L)
Geometric Coefficient of Variation 32.7
|
759 nanomol (nmol)* hours (h) / Litre (L)
Geometric Coefficient of Variation 27.1
|
PRIMARY outcome
Timeframe: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.Population: Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Maximum measured concentration of the analyte BI-113608 in plasma (Cmax).
Outcome measures
| Measure |
A : BI-113608
n=15 Participants
Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
|
B : BI-113608
n=15 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
|
C : BI-113608
n=15 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
|
D : BI-113608
n=15 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
|
E : BI-113608
n=14 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
|
|---|---|---|---|---|---|
|
Maximum Measured Concentration of the Analyte BI-113608 in Plasma (Cmax)
|
271 nmol/L
Geometric Coefficient of Variation 44.6
|
242 nmol/L
Geometric Coefficient of Variation 47.5
|
132 nmol/L
Geometric Coefficient of Variation 77.8
|
196 nmol/L
Geometric Coefficient of Variation 50.0
|
227 nmol/L
Geometric Coefficient of Variation 53.1
|
SECONDARY outcome
Timeframe: PK plasma samples were taken at: 2 hours (h) before drug administration and 15 min, 30 min, 45 min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 14h, 24h, 48h, 72h after drug administration.Population: Pharmacokinetic (PK) set: It included all treated subjects who provided at least 1 observation for at least 1 primary PK endpoint without important protocol violations relevant to the evaluation of PK.
Area under the concentration-time curve of the analyte BI-113608 in plasma over the time interval from 0 extrapolated to infinity (AUC 0-infinity).
Outcome measures
| Measure |
A : BI-113608
n=15 Participants
Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
|
B : BI-113608
n=15 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
|
C : BI-113608
n=15 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
|
D : BI-113608
n=15 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
|
E : BI-113608
n=14 Participants
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve of the Analyte BI-113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity)
|
938 nmol*h/L
Geometric Coefficient of Variation 27.4
|
926 nmol*h/L
Geometric Coefficient of Variation 31.2
|
650 nmol*h/L
Geometric Coefficient of Variation 39.3
|
902 nmol*h/L
Geometric Coefficient of Variation 32.7
|
761 nmol*h/L
Geometric Coefficient of Variation 27.1
|
Adverse Events
A : BI-113608
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
B : BI-113608
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
C : BI-113608
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Pantoprazole 40mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
D : BI-113608
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
E : BI-113608
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A : BI-113608
n=15 participants at risk
Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
|
B : BI-113608
n=15 participants at risk
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
|
C : BI-113608
n=15 participants at risk
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
|
Pantoprazole 40mg
n=15 participants at risk
Participants received single dose of Pantoprazole 40mg alone twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
|
D : BI-113608
n=15 participants at risk
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
|
E : BI-113608
n=14 participants at risk
Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Lacrimation increased
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
General disorders
Feeling cold
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
7.1%
1/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
7.1%
1/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
7.1%
1/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Nervous system disorders
Headache
|
33.3%
5/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
33.3%
5/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
33.3%
5/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
13.3%
2/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
13.3%
2/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
7.1%
1/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
7.1%
1/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
7.1%
1/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
|
Vascular disorders
Haematoma
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
6.7%
1/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/15 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
0.00%
0/14 • From first drug administration until 14 days after the last drug administration, up to 42 days.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place