Safety, Tolerability and Pharmacokinetics of BI 1026706 in Healthy Chinese and Japanese Male Volunteers
- Conditions
- Healthy
- Interventions
- Drug: PlaceboDrug: BI 1026706
- Registration Number
- NCT02652416
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses (SRD) followed by multiple rising doses (MRD)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 72
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (SRD part) Placebo placebo Placebo (MD part) Placebo placebo SRD part (high dose) BI 1026706 Chinese, Japanese both MD part (high dose) BI 1026706 Chinese, Japanese both SRD part (low dose) BI 1026706 Chinese, Japanese both SRD part (medium dose) BI 1026706 Chinese, Japanese both
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Drug-related Adverse Events (AEs) From first drug administration to 4 days after last drug intake, up to 19 days. 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.
- Secondary Outcome Measures
Name Time Method Cmax -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. This outcome measure presents maximum measured concentration of the analyte \[BI 1026706\] in plasma.
TS-SRD part: This subject set included all subjects who were dispensed BI 1026706 and were documented to have taken at least 1 dose of investigational treatment in the SRD part. All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint.Tmax -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. This outcome measure presents time from dosing to maximum measured concentration of the analyte \[BI 1026706\] in plasma.
All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint.AUC0-12 -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. This outcome measure presents area under the concentration-time curve of the analyte \[BI 1026706\] in plasma over the time interval from 0 extrapolated to 12 hours (AUC0-12).
All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint.AUC0-infinity -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. This outcome measure presents area under the concentration-time curve of the analyte \[BI 1026706\] in plasma over the time interval from 0 extrapolated to infinity.
All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint.t1/2 -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration. This outcome measure presents terminal half-life of the analyte \[BI 1026706\] in plasma.
All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint.Cmax,ss 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration. This outcome measure presents maximum measured concentration of the analyte \[BI 1026706\] in plasma at steady state over a uniform dosing interval tau.
TS-MD part: This subject set included all subjects from the 100 mg group in the SRD part who were dispensed BI 1026706 and were documented to have taken at least 1 dose of investigational treatment in the MD part. All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint.Tmax,ss 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration. This outcome measure presents time from last dosing to maximum concentration of the analyte \[BI 1026706\] in plasma at steady state (tmax,ss) .
All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint.AUC Tau,ss 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration. This outcome measure presents area under the concentration-time curve of the analyte \[BI 1026706\] in plasma at steady state over a uniform dosing interval tau (AUC tau,ss).
All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint.
Trial Locations
- Locations (1)
Souseikai Hakata Clinic
🇯🇵Fukuoka, Fukuoka, Japan