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)

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) - A study to test how well men tolerate different doses of BI 3006337

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51833

Enrollment

Registered

2022-10-10

Start date

2022-11-07

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver disease

Interventions

Group 1, Day 1, BI 3006337 0.2 mg (6 subjects) or placebo (2 subjects) once Group 2, Day 1 BI 3006337 0.5 mg (6 subjects) or placebo (2 subjects) once Group 3, Day 1 BI 3006337 1 mg (6 subjects) or

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 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 =20.0 to

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To investigate safety, tolerability and pharmacokinetics of single doses of BI 3006337 in healthy male subjects	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)