Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetics of BI 1026706 in Healthy Chinese and Japanese Male Volunteers (NCT NCT02652416)

Results Overview

The percentage of subjects with drug-related AEs indicate the safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses of 25 mg, 50 mg, and 100 mg, followed by multiple doses of 100 mg bid.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

72 participants

Primary outcome timeframe

From first drug administration to 4 days after last drug intake, up to 19 days.

Results posted on

2019-07-11

Participant Flow

This was a randomised, double-blind, placebo-controlled, single-centre trial investigating single rising dose (SRD) groups (25 milligram (mg), 50 mg and 100 mg) and a multiple dose (MD) (100 mg) in healthy Chinese and Japanese male subjects. This trial had an SRD plus MD nested design. All subjects from SRD 100 mg also participated in the MD part.

Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue therapies was allowed for all subjects as required.

Participant milestones

Participant milestones
Measure	Placebo The subjects were administered film-coated tablets matching placebo orally with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h).	BI 1026706 25 mg The subjects were administered 25 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h.	BI 1026706 50 mg The subjects were administered 50 mg \[25 mg\*2\] film-coated tablets single dose orally with 240 mL water after an overnight fast of at least 10h.	BI 1026706 100 mg The subjects were administered 100 mg film-coated tablet \[SRD\] as single dose followed with 100 mg film-coated tablets \[MD\] twice daily for 11 days with a final single dose in the morning of Day 12 orally with 240 mL water after an overnight fast of at least 10h.
Overall Study STARTED	18	18	18	18
Overall Study Subjects Who Participated in MD Part	6	0	0	18
Overall Study COMPLETED	18	18	18	18
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety, Tolerability and Pharmacokinetics of BI 1026706 in Healthy Chinese and Japanese Male Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=18 Participants The subjects were administered film-coated tablets matching placebo orally with 240 milliliter (mL) water after an overnight fast of at least 10 hours (h).	BI 1026706 25 mg n=18 Participants The subjects were administered 25 mg film-coated tablet single dose orally with 240 mL water after an overnight fast of at least 10h.	BI 1026706 50 mg n=18 Participants The subjects were administered 50 mg \[25 mg\*2\] film-coated tablets single dose orally with 240 mL water after an overnight fast of at least 10h.	BI 1026706 100 mg n=18 Participants The subjects were administered 100 mg film-coated tablet \[SRD\] as single dose followed with 100 mg film-coated tablets \[MD\] twice daily for 11 days with a final single dose in the morning of Day 12 orally with 240 mL water after an overnight fast of at least 10h.	Total n=72 Participants Total of all reporting groups
Age, Continuous	30.4 Years STANDARD_DEVIATION 7.74 • n=5 Participants	28.6 Years STANDARD_DEVIATION 7.83 • n=7 Participants	26.4 Years STANDARD_DEVIATION 5.72 • n=5 Participants	28.1 Years STANDARD_DEVIATION 5.40 • n=4 Participants	28.4 Years STANDARD_DEVIATION 6.78 • n=21 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
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	18 Participants n=4 Participants	72 Participants n=21 Participants

PRIMARY outcome

Timeframe: From first drug administration to 4 days after last drug intake, up to 19 days.

Population: Treated set (TS) : This subject set included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of investigational treatment.

The percentage of subjects with drug-related AEs indicate the safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses of 25 mg, 50 mg, and 100 mg, followed by multiple doses of 100 mg bid.