Phase 1
Completed N=80
Safety Tolerability and Pharmacokinetic of BI 409306
Healthy
Source: ClinicalTrials.gov NCT01343706 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Percentage of Subjects With Drug-related Adverse Events — 0.0; 0.0; 0.0; 33.3 Percentage of subjects
Summary
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy male genotyped volunteers following oral administration of single rising doses.
The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when administered as immediate release solid oral dosage compared to oral drinking solution and (3) to compare the safety and pharmacokinetic profiles between two different groups of genotyped subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Drug-related Adverse Events |
0.0; 0.0; 0.0; 33.3; 0.0; 16.7 | — |
| PRIMARY Percentage of Subjects With Clinical Relevant Abnormalities for Physical Examination, Vital Signs, Clinical Laboratory Tests, Oral Body Temperature and ECG |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Subjects Per Category for Assessment of Tolerability by Investigator |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Change From Baseline in Bond & Lader (B&L) Visual Analogue Scales (VAS) |
-0.33; -0.04; -0.84; -1.18; -0.13; 0.09 | — |
| SECONDARY Area Under the Concentration-time Curve of the BI 409306 in Plasma From Time 0 to Time of Last Quantifiable Data Point (AUC0-24) |
3.96; 20.90; 76.70; 75.60; 96.00; 351.00 | — |
| SECONDARY Area Under the Concentration-time Curve of the BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
3.95; 20.90; 76.70; 75.60; 95.90; 351.00 | — |
| SECONDARY Maximum Measured Concentration of the BI 409306 in Plasma (Cmax) |
3.54; 18.80; 56.40; 55.90; 99.80; 300.00 | — |
| SECONDARY Amount of BI 409306 Eliminated in Urine From the Time Point t1 to Time Point t2 (Ae0-4) |
31.00; 93.60; 98.10; 148.00; 840.00; 953.00 | — |
Eligibility Criteria
Inclusion criteria
- Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
- Age > 21 and Age 18.5 and BMI 450 ms);
- A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Data sourced from ClinicalTrials.gov (NCT01343706). 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.