Safety, tolerability, pharmacokinetics and pharmacodynamics of single rising subcutaneous doses of BI 3006337 in healthy male subjects (single-blind, partially randomised within dose groups, placebo-controlled, parallel (sequential) group design)
- Conditions
- Liver disease10000546
- Registration Number
- NL-OMON51833
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1. Healthy male subjects according to the assessment of the investigator, as
based on a complete medical history including a physical examination, vital
signs (Temperature, BP, PR), 12-lead ECG, neurological examination, and
clinical laboratory tests
2. Age of >=18 to <=55 years at SCR
3.BMI of >=20.0 to <32.0 kg/m2 at SCR
4. A minimum absolute BW of 70 kg at SCR
1.Female gender
2. Any finding in the medical examination (including BP, PR or ECG) or
neurological examination deviating from normal and assessed as clinically
relevant by the investigator
3. 3 times repeated measurements of systolic BP outside the range of 90 to 150
mmHg, diastolic BP outside the range of 50 to 90 mmHg, or PR outside the range
of 40 to 100 bpm. In case of documented white coat hypertension the decision
for eligibility is left to the investigator.
4. Any laboratory value outside the reference range that the investigator
considers to be of clinical relevance, in particular, hepatic parameters ALT
(1.25xULN), AST
(1.25xULN) and T-BIL (1.5xULN) or renal parameters (creatinine 1.25xULN)
exceeding the Upper Limit of Normal (ULN) as specified: after 2 times repeated
measurements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate safety, tolerability and pharmacokinetics of single doses of BI<br /><br>3006337 in healthy male subjects</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>