Phase 1
N=65
Safety, Tolerability and Pharmacokinetics of BI 409306 Tablets in Healthy Asian Male Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01841112 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Percentage (%) of Subjects With Drug-related Adverse Events (AEs) — 13.3; 9.1; 36.4; 57.9 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo (Drug); BI-409306 25 milligram (mg) SD (Drug); BI-409306 50 mg SD (Drug); BI-409306 100 mg SD (Drug); BI-409306 100 mg MD (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage (%) of Subjects With Drug-related Adverse Events (AEs) |
13.3; 9.1; 36.4; 57.9; 83.3; 83.3 | — |
| SECONDARY Maximum Measured Concentration of a Single Dose of BI 409306 in Plasma (Cmax) |
292; 824; 1970; 4020; 496; 914 | — |
| SECONDARY Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) |
376; 1070; 2020; 7550; 504; 985 | — |
| SECONDARY Area Under the Concentration-time Curve of a Single Dose of BI 409306 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz) |
375; 1040; 2020; 7550; 504; 985 | — |
| SECONDARY Maximum Measured Concentration of the Metabolite CD 13896 in Plasma (Cmax) |
926; 1080 | — |
| SECONDARY Maximum Measured Concentration of the Metabolite CD 14084 in Plasma (Cmax) |
3800; 4340 | — |
| SECONDARY Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) |
1650; 1520 | — |
| SECONDARY Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC 0-infinity) |
8670; 9060 | — |
| SECONDARY Area Under the Concentration-time Curve of the Metabolite CD 13896 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz). |
1650; 1510 | — |
| SECONDARY Area Under the Concentration-time Curve of the Metabolite CD 14084 in Plasma Over the Time Interval 0 to the Last Quantifiable Data Point (AUC0-tz). |
8670; 9060 | — |
Summary
Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 409306 tablets in healthy Chinese and Japanese male volunteers of a known genotype as specified in the study protocol.
Eligibility Criteria
Inclusion criteria
- Healthy male Chinese and Japanese volunteers
- Age between 20 and 45 years
- BMI between 18.5 and 25 kg/m2 (Body Mass Index)
- Known genotype as specified in the study protocol
- Subjects must be able to understand and comply with study requirements
Exclusion criteria
- Any deviation from healthy condition
Data sourced from ClinicalTrials.gov (NCT01841112). 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.