Single Rising Oral Doses of BI 1021958 in Healthy Chinese and Japanese Male Volunteers

NCT01638598 | Completed Phase 1

• 1 other identifier: 1310.3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after single rising doses (SRD) in healthy Asian male volunteers

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The number (%) of subjects with related adverse events.

  up to 17 days postdose

Secondary Outcomes (5)

• AUC0-inf (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity)

  up to day 4 postdose

• AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)

  up to day 4 postdose

• AUC0-12 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 12 h)

  up to day 4 postdose

• Cmax (maximum measured concentration of BI 1021958 in plasma)

  up to day 4 postdose

• AUC0-24 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 24 h)

  up to day 4 postdose

Study Arms (5)

BI 1021958 dose group 1

EXPERIMENTAL

subject to receive a tablet containing dose group 1 BI 1021958 single dose

Drug: Test drug; Drug: matching placebo

BI 1021958 dose group 2

EXPERIMENTAL

subject to receive a tablet containing dose group 2 BI 1021958 single dose

Drug: matching placebo; Drug: Test drug

BI 1021958 dose group 3

EXPERIMENTAL

subject to receive a tablet containing dose group 3 BI 1021958 single dose

Drug: Test drug; Drug: matching placebo

BI 1021958 dose group 4

EXPERIMENTAL

subject to receive a tablet containing dose group 4 BI 1021958 single dose

Drug: matching placebo; Drug: Test drug

BI 1021958 dose group 5

EXPERIMENTAL

subject to receive a tablet containing dose group 5 BI 1021958 single dose

Drug: Test drug; Drug: matching placebo

Interventions

matching placebo DRUG

matching placebo in each dose level

BI 1021958 dose group 2

Test drug DRUG

BI 1021958

BI 1021958 dose group 3

Eligibility Criteria

• Age: 20 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 Japanese; born in Japan, be a current Japanese passport holder, have lived outside of Japan \<5 years, and have parents and grandparents who were all born in Japan Chinese; ethnic 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
• Age within the range of 20 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 GCP and the local legislation.

You may not qualify if:

• Any finding of the medical examination (including Blood Pressure, Pulse Rate, ECG and Safety laboratory) deviating from normal and of clinical relevance
• Any evidence of a clinically relevant concomitant disease
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Surgery of the gastrointestinal tract (except appendectomy)
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of relevant orthostatic hypotension, fainting spells or blackouts.
• Chronic or relevant acute infections
• History of relevant allergy/hypersensitivity (including allergy/hypersensitivity to the study drug or its excipients)
• Intake of drugs with a long half-life (more than 24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to administration
• Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval (based on the knowledge at the time of protocol preparation) within 10 days prior to administration
• Participation in another trial with an investigational drug administration within 2 months prior to administration
• Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (more than 30 g/day)
• Drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1310.3.8201 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

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 2, 2012
• First Posted: July 12, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

KR (1)