Phase 1
Completed N=60
To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers
Healthy
Source: ClinicalTrials.gov NCT02093819 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Subjects With Drug-related Adverse Events — 6.7; 0.0; 0.0; 0.0 percentage of participants
Summary
To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Drug-related Adverse Events |
6.7; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Cmax (Maximum Measured Concentration of the Analyte in Plasma) |
15.2; 44.0; 154; 250; 482; 1060 | — |
| SECONDARY AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity) |
72.8; 195; 566; 992; 1770; 3970 | — |
Eligibility Criteria
Inclusion criteria
- Healthy males according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory
- Age 18 to 50 years (incl.)
- Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
- Known genotype of CYP2C9 isoenzyme
Exclusion criteria
- Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
- Repeated measurement of systolic blood pressure outside of ranges 90-140 mmHg, diastolic blood pressure outside of ranges 50-90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
- Diseases of the central nervous system (such as epilepsy), other peripheral neurological disorders or psychiatric disorders
Data sourced from ClinicalTrials.gov (NCT02093819). 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.