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

NCT ID: NCT01971502

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-02-28

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BI 1060469 single rising dose part

single rising doses given as tablet

Group Type: EXPERIMENTAL

Placebo to BI 1060469

Intervention Type: DRUG

single rising doses

BI 1060469

Intervention Type: DRUG

single rising doses

BI 1060469 food effect part

given as tablet fasted and fed

Group Type: EXPERIMENTAL

BI 1060469

Intervention Type: DRUG

food effect

Interventions

Placebo to BI 1060469

single rising doses

Intervention Type: DRUG

BI 1060469

food effect

Intervention Type: DRUG

BI 1060469

single rising doses

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1333.1.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Countries

Germany

Other Identifiers

2013-001475-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1333.1

Identifier Type: -

Identifier Source: org_study_id