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

NCT02133482 | Withdrawn Phase 1

• 2 other identifiers: 1352.12014-001061-27
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of subjects with drug-related adverse events

  up to 19 days postdose

Secondary Outcomes (2)

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

  up to 120 hours postdose

• Cmax (maximum measured concentration of the analyte in plasma)

  up to 120 hours postdose

Study Arms (2)

BI 639667

EXPERIMENTAL

single rising doses given as oral solution

Drug: BI 639667

Placebo

PLACEBO COMPARATOR

placebo solution

Drug: Placebo

Interventions

Placebo DRUG

placebo solution

Placebo

BI 639667 DRUG

oral solution BI 639667, single rising doses

BI 639667

Eligibility Criteria

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

You may qualify if:

• Healthy male subjects
• age of 18 to 50 years
• body mass index (BMI) of 18.5 to 29.9 kg/m2

You may not qualify if:

• 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
• 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
• 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 (except appendectomy and simple hernia repair)
• Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders

Sponsors & Collaborators

• Boehringer Ingelheim: lead

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: May 7, 2014
• First Posted: May 8, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 15, 2014

Record last verified: 2014-07