Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667

NCT ID: NCT02133482

Last Updated: 2014-07-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-10-31

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 639667 in healthy male subjects following oral administration of single rising doses.

Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality as well as investigation of linearity and pharmacodynamics (PD) of BI 639667 after single dosing and the assessment of the PK/PD relationship.

Conditions

Healthy

Study Design

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

Study Groups

BI 639667

single rising doses given as oral solution

Group Type: EXPERIMENTAL

BI 639667

Intervention Type: DRUG

oral solution BI 639667, single rising doses

Placebo

placebo solution

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo solution

Interventions

Placebo

placebo solution

Intervention Type: DRUG

BI 639667

oral solution BI 639667, single rising doses

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male subjects

2. age of 18 to 50 years

3. body mass index (BMI) of 18.5 to 29.9 kg/m2

Exclusion Criteria

1. Any finding in the medical examination (including BP, pulse rate (PR) or ECG) is deviating from normal and judged as clinically relevant by the investigator

2. Repeated measurement of systolic blood pressure greater than 140 mmHg, diastolic blood pressure greater than 90 mmHg, or pulse rate outside the range of 50 to 90 mmHg at screening

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

4. Any evidence of a concomitant disease judged as clinically relevant by the investigator

5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

6. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and simple hernia repair)

7. Diseases of the central nervous system (such as epilepsy), other 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

Other Identifiers

2014-001061-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1352.1

Identifier Type: -

Identifier Source: org_study_id