Phase 1
N=97
Safety, Tolerability and Pharmacokinetics of BI 113608 in Healthy Asian and Caucasian Male Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01922349 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Number (%) of Subjects With Drug-related Adverse Events — 28.0; 51.9; 33.3; 92.6 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 113608 (Drug); Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number (%) of Subjects With Drug-related Adverse Events |
28.0; 51.9; 33.3; 92.6 | — |
| SECONDARY Cmax (Maximum Measured Concentration of the Analyte in Plasma) |
45.8; 72.7; 38.9; 191; 217; 494 | — |
| SECONDARY Tmax (Time From Dosing to Maximum Measured Concentration in Plasma) |
1.00; 0.75; 0.75; 0.50; 0.75; 0.50 | — |
| SECONDARY Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-infinity) |
199; 288; 196; 648; 775; 1560 | — |
| SECONDARY AUC0-tz (Area Under the Concentration-time Curve of the Analyte in Plasma From Time 0 to Time of Last Quantifiable Data Point) |
197; 285; 193; 645; 773; 1560 | — |
| SECONDARY t1/2 (Terminal Half-life of the Analyte in Plasma After the First Dose) |
12.7; 12.1; 15.4; 11.7; 10.1; 11.7 | — |
| SECONDARY Cmax,ss |
42.5; 66.5; 33.7; 223; 234; 500 | — |
| SECONDARY Tmax,ss |
0.75; 0.75; 1.00; 0.75; 0.75; 0.75 | — |
| SECONDARY AUCtau,ss |
222; 273; 199; 860; 823; 2000 | — |
| SECONDARY t1/2,ss |
13.6; 15.3; 16.6; 13.2; 13.1; 13.4 | — |
| SECONDARY RA,Cmax (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Oral Administration Over a Uniform Dosing Interval Tau) |
0.928; 0.915; 0.866; 1.17; 1.08; 1.01 | — |
| SECONDARY RA,AUC (Accumulation Ratio of the Analyte in Plasma at Steady State After Multiple Dose Administration Over a Uniform Dosing Interval Tau) |
1.32; 1.11; 1.27; 1.49; 1.19; 1.42 | — |
Summary
Safety, tolerability and pharmacokinetics of single and multiple oral doses of BI 113608 in healthy Chinese, Japanese and Caucasian male volunteers.
Eligibility Criteria
Inclusion criteria
-Healthy male volunteers according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead Electrocardiogram, clinical laboratory tests
- Chinese ethnicity, Japanese ethnicity according to the following criteria Japanese; born in Japan, be a current Japanese passport holder, have lived outside of Japan 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 20 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms);
- A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
Data sourced from ClinicalTrials.gov (NCT01922349). 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.