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

NCT01971502 | Completed Phase 1

• 2 other identifiers: 1333.12013-001475-20
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of subjects with drug- related adverse events.

  up to 2 weeks

Secondary Outcomes (3)

• Cmax (maximum measured concentration of BI 1060469 in plasma)

  up to 2 weeks

• AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity)

  up to 2 weeks

• AUC0-tz (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 up to the last quantifiable data point)

  up to 2 weeks

Study Arms (2)

BI 1060469 single rising dose part

EXPERIMENTAL

single rising doses given as tablet

Drug: Placebo to BI 1060469; Drug: BI 1060469

BI 1060469 food effect part

EXPERIMENTAL

given as tablet fasted and fed

Drug: BI 1060469

Interventions

Placebo to BI 1060469 DRUG

single rising doses

BI 1060469 single rising dose part

BI 1060469 DRUG

food effect

BI 1060469 food effect part

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Age within the range of 18 to 50 years
• Body mass index within the range of 18.5 and 29.9 kg/m2
• Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation.

You may not qualify if:

• 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.
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• In the SRD: serum creatinine laboratory value outside the normal range
• Glomerular filtration rate (GFR) according to CKD-EPI (Chronic Kidney Disease - Epidemiology Collaboration)-Formula \< 60 ml/ min
• Current or history of relevant kidney, urinary tract diseases or abnormalities (i.e. nephrolithiasis, hydronephrosis, acute or chronic nephritis, renal injury, renal failure, infections)
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1333.1.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 29, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 27, 2014

Record last verified: 2014-07

Locations

DE (1)