Phase 1
Completed N=64
Single Rising Doses of BI 655064 in Healthy Chinese and Japanese Male Volunteers
Healthy
Source: ClinicalTrials.gov NCT01917916 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Number of Participants With Investigator Defined Drug-related Adverse Events — 2; 1; 4; 2 Participants
Summary
Safety, tolerability, pharmacokinetics and pharmacodynamics of BI 655064 after single rising doses in healthy Asian male volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Investigator Defined Drug-related Adverse Events |
2; 1; 4; 2; 1 | — |
| SECONDARY Maximum Measured Concentration of BI 655064 in Plasma (Cmax) |
888; 5160; 8650; 15700; 1550; 7210 | — |
| SECONDARY Area Under the Concentration-time Curve of the Analyte BI 655064 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
330; 1120; 2910; 5610; 464; 2020 | — |
| SECONDARY 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) |
126; 1110; 2900; 5680; 365; 2010 | — |
Eligibility Criteria
Inclusion criteria
- Healthy males based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
- Chinese ethnicity, Japanese ethnicity according to the following criteria. Japanese: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who were all born in Japan. Chinese: ethnic Chinese, born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
- Age within the range of 20 to 45 years inclusive
- Body mass index within the range of 18.5 and 25 kg/m2 inclusive
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.
Exclusion criteria
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any disease or clinically relevant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the subject or interfere with the subjects participation in the trial or compromise the trial objectives
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant orthostatic hypotension, fainting spells or blackouts.
- Chronic or relevant acute infections
Data sourced from ClinicalTrials.gov (NCT01917916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.