Phase 1
Completed N=81
Safety of Single Rising Doses and Relative Bioavailability of BI 691751
Healthy
Source: ClinicalTrials.gov NCT01843972 ↗
Enrolled (actual)
81
Serious AEs
1.2%
Results posted
Feb 2016
Primary outcomePrimary: AUC0-72h (Part II) — 2740; 3050; 2800 nmol*h/L
Summary
To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).
To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-72h (Part II) |
2740; 3050; 2800 | — |
| PRIMARY Cmax (Part II) |
223; 207; 220 | — |
| PRIMARY Frequency of Subjects With Drug-related Adverse Events (Part I) |
1; 0; 1; 0; 0; 0 | — |
| SECONDARY Cmax (Part I) |
3.45; 18.3; 88.9; 729; 1320; 3320 | — |
| SECONDARY AUC0-infinity (Part I) |
1140; 7250; 11900; 24500; 41000; 3630 | — |
| SECONDARY AUC0-tz |
29.5; 791; 6310; 11400; 24100; 40500 | — |
| SECONDARY t1/2 (Part I) |
65.4; 97.4; 74.9; 57.2; 78.3; 59.4 | — |
| SECONDARY Tmax (Part I) |
0.667; 0.667; 0.842; 0.500; 0.350; 0.667 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male subjects
- Subjects must be able to understand and comply with study requirements
- Age from 18 to 55 years
- BMI range: from 18.5 to 29.9 kg/m2
- Known genotype as specified in the study protocol
Exclusion criteria
- Any relevant deviation from healthy conditions
Data sourced from ClinicalTrials.gov (NCT01843972). 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.