Trial Outcomes & Findings for Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers (NCT NCT01917916)

NCT ID: NCT01917916

Last Updated: 2023-08-09

Results Overview

Number of participants with investigator defined drug-related adverse events (AEs) is reported.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

64 participants

Primary outcome timeframe

From study drug administration until end-of-study examination, up to 77 days.

Results posted on

2023-08-09

Participant Flow

This was a randomised, placebo-controlled, double-blind within dose groups, single rising dose study with 4 doses in Chinese and Japanese healthy volunteers.

All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

Participant milestones

Participant milestones
Measure	BI 655064 Dose Group 1 - 80 mg Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 80 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 2 - 120 mg Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 120 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 3 - 180 mg Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 180 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 4 - 240 mg Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 240 milligram (mg) of solution for injection of BI 655064.	Placebo Matching BI 655064 Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of solution for injection of Placebo matching BI 655064.
Overall Study STARTED	12	12	12	12	16
Overall Study COMPLETED	12	12	12	12	16
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BI 655064 Dose Group 1 - 80 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 80 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 2 - 120 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 120 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 3 - 180 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 180 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 4 - 240 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 240 milligram (mg) of solution for injection of BI 655064.	Placebo Matching BI 655064 n=16 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of solution for injection of Placebo matching BI 655064.	Total n=64 Participants Total of all reporting groups
Age, Continuous	27.5 Years STANDARD_DEVIATION 6.7 • n=5 Participants	24.6 Years STANDARD_DEVIATION 2.6 • n=7 Participants	26.7 Years STANDARD_DEVIATION 6.0 • n=5 Participants	29.7 Years STANDARD_DEVIATION 9.7 • n=4 Participants	26.1 Years STANDARD_DEVIATION 5.6 • n=21 Participants	26.8 Years STANDARD_DEVIATION 6.5 • n=10 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
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	12 Participants n=4 Participants	16 Participants n=21 Participants	64 Participants n=10 Participants

PRIMARY outcome

Timeframe: From study drug administration until end-of-study examination, up to 77 days.

Population: Treated Set (TS): This subject set included all subjects who were documented to have taken study medication.

Number of participants with investigator defined drug-related adverse events (AEs) is reported.

Outcome measures

Outcome measures
Measure	BI 655064 Dose Group 1 - 80 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 80 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 2 - 120 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 120 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 3 - 180 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 180 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 4 - 240 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 240 milligram (mg) of solution for injection of BI 655064.	Placebo Matching BI 655064 n=16 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of solution for injection of Placebo matching BI 655064.
Number of Participants With Investigator Defined Drug-related Adverse Events	2 Participants	1 Participants	4 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 3:00 hours:minutes (h:min) before and 08:00h, 12:00h, 24:00h, 36:00h, 48:00h, 72:00h, 96:00h, 108:00h, 120:00h, 168:00h, 264:00h, 432:00h, 648:00h, 984:00h, 1320:00h, 1656:00 h:min after BI 655064 administration.

Population: The pharmacokinetic (PK) set (PKS) included all subjects from the treated set (TS) who provided at least 1 secondary PK endpoint that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints. Only participants with evaluable results for this PK parameter are reported.

Maximum measured concentration of BI 655064 in plasma (Cmax) is reported.

Outcome measures

Outcome measures
Measure	BI 655064 Dose Group 1 - 80 mg n=11 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 80 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 2 - 120 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 120 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 3 - 180 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 180 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 4 - 240 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 240 milligram (mg) of solution for injection of BI 655064.	Placebo Matching BI 655064 Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of solution for injection of Placebo matching BI 655064.
Maximum Measured Concentration of BI 655064 in Plasma (Cmax) Chinese participants	888 nanogram (ng)/ (milliliter) mL Geometric Coefficient of Variation 501	5160 nanogram (ng)/ (milliliter) mL Geometric Coefficient of Variation 51.6	8650 nanogram (ng)/ (milliliter) mL Geometric Coefficient of Variation 41.1	15700 nanogram (ng)/ (milliliter) mL Geometric Coefficient of Variation 54.2	—
Maximum Measured Concentration of BI 655064 in Plasma (Cmax) Japanese participants	1550 nanogram (ng)/ (milliliter) mL Geometric Coefficient of Variation 315	7210 nanogram (ng)/ (milliliter) mL Geometric Coefficient of Variation 92.8	16300 nanogram (ng)/ (milliliter) mL Geometric Coefficient of Variation 73.6	21300 nanogram (ng)/ (milliliter) mL Geometric Coefficient of Variation 53.4	—

SECONDARY outcome

Population: The pharmacokinetic (PK) set (PKS) included all subjects from the treated (TS) who provided at least 1 secondary PK endpoint that was judged as PK evaluable and was not affected by protocol violations relevant to the statistical evaluation of PK endpoints. Only participants with evaluable results for this PK parameter are reported.

Area under the concentration-time curve of the analyte BI 655064 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) is reported.

Outcome measures

Outcome measures
Measure	BI 655064 Dose Group 1 - 80 mg n=10 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 80 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 2 - 120 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 120 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 3 - 180 mg n=12 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 180 milligram (mg) of solution for injection of BI 655064.	BI 655064 Dose Group 4 - 240 mg n=11 Participants Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of 240 milligram (mg) of solution for injection of BI 655064.	Placebo Matching BI 655064 Japanese and Chinese healthy participants were administered subcutaneously (s.c.) a single dose of solution for injection of Placebo matching BI 655064.
Area Under the Concentration-time Curve of the Analyte BI 655064 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) Chinese participants	330 microgram (µg)*hours (h)/mL Geometric Coefficient of Variation 111	1120 microgram (µg)*hours (h)/mL Geometric Coefficient of Variation 46.6	2910 microgram (µg)*hours (h)/mL Geometric Coefficient of Variation 60.1	5610 microgram (µg)*hours (h)/mL Geometric Coefficient of Variation 59.0	—
Area Under the Concentration-time Curve of the Analyte BI 655064 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) Japanese participants	464 microgram (µg)*hours (h)/mL Geometric Coefficient of Variation 74.1	2020 microgram (µg)*hours (h)/mL Geometric Coefficient of Variation 78.8	6430 microgram (µg)*hours (h)/mL Geometric Coefficient of Variation 83.3	7780 microgram (µg)*hours (h)/mL Geometric Coefficient of Variation 57.1	—

SECONDARY outcome

Area under the concentration-time curve of the analyte BI 655064 in the plasma over the time interval from 0 to the last measurable time point (AUC0-tz) is reported.