Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Single Escalating Doses of BI 1034020 Administered Intravenously or Subcutaneously to Male Healthy Volunteers (NCT NCT01958060)

NCT ID: NCT01958060

Last Updated: 2015-07-30

Results Overview

Percentage of subjects with investigator defined drug-related adverse events

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

from the first drug administration to end of trial, up to 50 days

Results posted on

2015-07-30

Participant Flow

This trial was initiated at two centres. As one of the trial centres did not enrol any subjects by the time of premature termination of the trial; the trial was conducted only at one centre.

Partially randomised, placebo-controlled within dose groups, single-blind, single rising dose, multiple centres (dose escalation intravenous \[iv\] bridging to subcutaneous \[sc\] in parallel). 35 subjects were enrolled and 32 subjects were treated.

Participant milestones

Participant milestones
Measure	Placebo Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.	BI 1034020 (5 mg/25 mL - iv) Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (10 mg/25 mL - iv) Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (20 mg/25 mL - iv) Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (50 mg/25 mL - iv) Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (100 mg/25 mL - iv) Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
Overall Study STARTED	10	6	6	5	7	1
Overall Study COMPLETED	8	6	6	5	6	1
Overall Study NOT COMPLETED	2	0	0	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.	BI 1034020 (5 mg/25 mL - iv) Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (10 mg/25 mL - iv) Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (20 mg/25 mL - iv) Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (50 mg/25 mL - iv) Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (100 mg/25 mL - iv) Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
Overall Study Not treated	2	0	0	0	1	0

Baseline Characteristics

Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of Single Escalating Doses of BI 1034020 Administered Intravenously or Subcutaneously to Male Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=8 Participants Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.	BI 1034020 (5 mg/25 mL - iv) n=6 Participants Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (10 mg/25 mL - iv) n=6 Participants Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (20 mg/25 mL - iv) n=5 Participants Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (50 mg/25 mL - iv) n=6 Participants Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (100 mg/25 mL - iv) n=1 Participants Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	Total n=32 Participants Total of all reporting groups
Age, Continuous	26.5 Year STANDARD_DEVIATION 4.3 • n=5 Participants	32.5 Year STANDARD_DEVIATION 3.9 • n=7 Participants	33.2 Year STANDARD_DEVIATION 3.4 • n=5 Participants	31.4 Year STANDARD_DEVIATION 4.0 • n=4 Participants	34.3 Year STANDARD_DEVIATION 4.0 • n=21 Participants	23.0 Year STANDARD_DEVIATION NA • n=10 Participants	31.0 Year STANDARD_DEVIATION 4.9 • n=115 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	1 Participants n=10 Participants	32 Participants n=115 Participants

PRIMARY outcome

Timeframe: from the first drug administration to end of trial, up to 50 days

Population: Treated Set (TS)

Percentage of subjects with investigator defined drug-related adverse events

Outcome measures

Outcome measures
Measure	Placebo n=8 Participants Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.	BI 1034020 (5 mg/25 mL - iv) n=6 Participants Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (10 mg/25 mL - iv) n=6 Participants Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (20 mg/25 mL - iv) n=5 Participants Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (50 mg/25 mL - iv) n=6 Participants Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (100 mg/25 mL - iv) n=1 Participants Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
Percentage of Subjects With Drug Related Adverse Events	37.5 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	0.0 percentage of participants	50.0 percentage of participants	100.0 percentage of participants

SECONDARY outcome

Timeframe: 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.

Population: Pharmacokinetic Set (PKS): This subject set included all subjects in the treated set who provide at least 1 observation for at least 1 secondary Pharmacokinetic (PK) endpoint without important protocol violations relevant to the evaluation of PK.

Maximum measured concentration of BI 1034020 in plasma (Cmax).

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.	BI 1034020 (5 mg/25 mL - iv) n=6 Participants Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (10 mg/25 mL - iv) n=5 Participants Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (20 mg/25 mL - iv) n=5 Participants Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (50 mg/25 mL - iv) Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (100 mg/25 mL - iv) Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
Cmax	1.50 μg/mL Geometric Coefficient of Variation 8.69	3.30 μg/mL Geometric Coefficient of Variation 17.6	6.90 μg/mL Geometric Coefficient of Variation 15.7	17.2 μg/mL Geometric Coefficient of Variation 11.5	—	—

SECONDARY outcome

Timeframe: 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.

Population: Pharmacokinetic set (PKS):

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf). AUC0-inf could be assessed only in 50 mg iv dose group as terminal phase was below lower limit of quantification (BLQ) for other dose groups. Therefore dose proportionality for AUC0-inf could not be performed in this trial.

Outcome measures

Outcome measures
Measure	Placebo n=4 Participants Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.	BI 1034020 (5 mg/25 mL - iv) Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (10 mg/25 mL - iv) Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (20 mg/25 mL - iv) Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (50 mg/25 mL - iv) Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.	BI 1034020 (100 mg/25 mL - iv) Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
AUC0-inf	314 μg*h/mL Geometric Coefficient of Variation 7.66	—	—	—	—	—

SECONDARY outcome

Timeframe: 2h before study drug administration and 0.25h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 168h, 336h, 504h, 672h, 840h and 1008h after drug administration on day 1.

Population: Pharmacokinetic set (PKS)

Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose (AUC0-tz ).