Phase 1
N=20
Interaction of BI 691751 With Itraconazole
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02044393 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration) — 2830; 2090; 25000; 21600 nmol*h/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- itraconazole (Drug); BI 691751 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-tz (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 up to the Last Quantifiable Concentration) |
2830; 2090; 25000; 21600 | — |
| PRIMARY Cmax (Maximum Measured Concentration of BI 691751 in Plasma and Whole Blood) |
157; 150; 217; 203 | — |
| SECONDARY AUC0-infinity (Area Under the Concentration-time Curve of BI 691751 in Plasma and Whole Blood Over the Time Interval From 0 Extrapolated to Infinity) |
3160; 2360; 27700; 24600 | — |
Summary
Investigation of the relative bioavailability of a single dose of BI 691751 when given alone and together with itraconazole; safety and tolerability
Eligibility Criteria
Inclusion criteria
- Healthy male subjects
- body mass index (BMI) of 18.5 to 29.9 kg/m2
- Subjects must be able to understand and comply with study requirements
Exclusion criteria
- Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator.
- Pulse rate outside 45 to 100 bpm or repeated measurements of systolic BP outside 90 to 140 mmHg or diastolic BP outside 50 to 90 mmHg.
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any alanine transaminase (ALT/GPT), aspartate transaminase (AST/GOT), or gammaglutamyltransferase (GGT) value outside the reference range at the screening examination
- Any evidence of a concomitant disease judged clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
- Any history of relevant liver diseases such as disturbance of liver function, jaundice, drug induced liver injury, Dubin-Johnson syndrome, Rotor syndrome, or liver tumors
Data sourced from ClinicalTrials.gov (NCT02044393). 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.