Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1060469 in Healthy Asian Male Volunteers

NCT02183545 | Completed Phase 1

• 1 other identifier: 1333.3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this single rising dose study (SRD) is to investigate safety, tolerability, and pharmacokinetics of single rising doses of BI 1060469 in healthy Asian male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• number of subjects with drug-related adverse events

  up to 14 days after drug administration

Secondary Outcomes (3)

• Maximum concentration of BI 1060469 (Cmax)

  up to 72 hours after drug administration

• Area Under the concentration-time curve of BI 1060469 over time interval from 0 interpolated to infinity ((AUC0-infinity)

  up to 72 hours after drug administration

• Area Under the concentration-time curve of BI 1060469 (AUC0- tz)

  up to 72 hours after drug administration

Study Arms (2)

BI 1060469

EXPERIMENTAL

single rising doses given as tablet

Drug: BI 1060469

Placebo

PLACEBO COMPARATOR

given as tablet (matching placebo of BI 1060469)

Drug: Placebo

Interventions

BI 1060469 DRUG

single rising doses given as tablet

BI 1060469

Placebo DRUG

given as tablet (matching placebo of BI 1060469)

Placebo

Eligibility Criteria

• Age: 18 Years - 45 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 ECG, and clinical laboratory tests
• Chinese ethnicity, Japanese ethnicity according to the following criteria:
• Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in china Japanese; born in Japan, have lived outside of Japan \<10 years, and have parents and grandparents who were all born in Japan
• Age within the range of 18 to 45 years
• Body mass index within the range of 18.5 and 25 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, pulse rate or ECG(electrocardiogram)) deviating from normal and judged clinically relevant by the investigator. Pulse rate outside the range of 50-90 beat per minute 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
• Serum creatinine laboratory value outside the normal range
• Glomerular Filtration Rate 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
• Diseases of the central nervous system (such as epilepsy), central neurological disorders or psychiatric disorders
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• Relevant chronic or acute infections
• History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
• Intake of drugs with a long half-life (greater than 24 hours) within 30 days or less than 10 half-lives of the respective drug prior to study drug administration
• Intake of any NSAIDs(Nonsteroidal anti-inflammatory drugs), COX2(Cyclooxygenase-2) inhibitors, aspirin, ACE(Angiotensin Converting Enzyme) inhibitors, H2-blockers or OTC(Over the Counter Drug)- or nutripharmaceuticals between screening examination and drug administration
• Use of drugs that might reasonably influence the results of the trial (including renal function measurements) or that might prolong the QT/QTc interval within 14 days prior to study drug administration
• Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

1333.3.82002 Boehringer Ingelheim Investigational Site

Busan, South Korea

Location

1333.3.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 8, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 16, 2014

Record last verified: 2014-10

Locations

KR (2)