To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers

NCT ID: NCT02093819

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-06-30

Brief Summary

To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.

Conditions

Healthy

Study Design

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

Study Groups

BI 416970 single rising dose part

single rising dose given as tablet

Group Type: EXPERIMENTAL

Placebo to BI 416970

Intervention Type: DRUG

single rising doses

BI 416970

Intervention Type: DRUG

single rising doses

Interventions

Placebo to BI 416970

single rising doses

Intervention Type: DRUG

BI 416970

single rising doses

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy males according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (Blood Pressure, Pulse Rate), 12-lead electrocardiogram, and clinical laboratory
• Age 18 to 50 years (incl.)
• Body Mass Index 18.5 to 29.9 kg/m2 (incl.)
• Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation
• Known genotype of CYP2C9 isoenzyme

Exclusion Criteria

• Any finding in the medical examination (including Blood Pressure, Pulse Rate or Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside of ranges 90-140 mmHg, diastolic blood pressure outside of ranges 50-90 mmHg, or pulse rate outside the range of 50 to 90 bpm
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease judged as clinically relevant by the investigator
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
• Diseases of the central nervous system (such as epilepsy), other peripheral neurological disorders or psychiatric disorders

• 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

1345.1.1 Boehringer Ingelheim Investigational Site

Biberach, , Germany

Countries

Germany

Other Identifiers

2013-003560-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1345.1

Identifier Type: -

Identifier Source: org_study_id