Phase 1
N=20
Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01787032 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) — 494; 1840; 1320 nanomol*hours/litre (nmol*h/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 113608 (Drug); Ketoconazole (Drug); Voriconazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) |
494; 1840; 1320 | — |
| PRIMARY Maximum Measured Concentration of BI 113608 in Plasma (Cmax) |
102; 267; 218 | — |
| SECONDARY Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞) |
496; 1850; 1320 | — |
| SECONDARY Time From Dosing to Maximum Measured Concentration of BI 113608 in Plasma (Tmax) |
1.25; 1.40; 1.43 | — |
| SECONDARY Terminal Half-life of BI 113608 in Plasma (t1/2) |
11.0; 9.20; 10.6 | — |
Summary
The primary objective of this trial is to investigate the relative bioavailability of a single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state. The assessment of safety and tolerability of BI 113608 administered alone and upon co-administration will be an additional objective of this trial.
Eligibility Criteria
Inclusion criteria
- Healthy male subjects
Exclusion criteria
- Any relevant deviation from healthy conditions.
Data sourced from ClinicalTrials.gov (NCT01787032). 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.