Interaction of BI 691751 With Itraconazole

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

Investigation of the relative bioavailability of a single dose of BI 691751 when given alone and together with itraconazole; safety and tolerability

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Hydroxyitraconazole; Itraconazole

Criteria

Inclusion criteria:

1. Healthy male subjects

2. body mass index (BMI) of 18.5 to 29.9 kg/m2

3. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

1. 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.

2. 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.

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

4. Any alanine transaminase (ALT/GPT), aspartate transaminase (AST/GOT), or gammaglutamyltransferase (GGT) value outside the reference range at the screening examination

5. Any evidence of a concomitant disease judged clinically relevant by the investigator

6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders

7. 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