Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses and Effect of Food on the Bioavailability of BI 1060469

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo to BI 1060469; Drug: BI 1060469

Study type: Interventional

Funder types: Industry

Identifiers

NCT01971502

2013-001475-20 (EudraCT Number)

1333.1

Details and patient eligibility

About

The objective of the single rising dose part (SRD) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male subjects. The objective of the food effect part (FE) is to investigate the relative bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.

Enrollment: 68 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
2. Age within the range of 18 to 50 years
3. Body mass index within the range of 18.5 and 29.9 kg/m2
4. Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation.

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. Pulse rate outside the range of 50-90 bpm or blood pressure outside the ranges of 90-140 for systolic and 50-90 mmHg for diastolic blood pressure if confirmed by repeat measurement.
2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
3. In the SRD: serum creatinine laboratory value outside the normal range
4. Glomerular filtration rate (GFR) according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration)-Formula < 60 ml/ min
5. Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
7. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

BI 1060469 single rising dose part

Experimental group

Description:

single rising doses given as tablet

Treatment:

Drug: BI 1060469

Drug: Placebo to BI 1060469

Drug: BI 1060469

BI 1060469 food effect part

Experimental group

Description:

given as tablet fasted and fed

Treatment:

Drug: BI 1060469

Drug: BI 1060469