Single Rising Dose Study to Assess Safety, Tolerability and Pharmacokinetics of BI 661051.

NCT01343719 | Completed Phase 1

• 2 other identifiers: 1296.12010-022465-96
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of treatment with BI 661051 rising single doses administered as oral drinking solution (powder in bottle) in healthy male subjects. The primary objective is to investigate the safety and tolerability of treatment with BI 661051. The secondary objectives are (1) to evaluate the single dose pharmacokinetics of BI 661051, (2) to explore dose proportionality, (3) to explore the relative bioavailability when BI 661051 is administered as tablet at two dose levels compared to oral drinking solution and (4) to assess the effect on the bioavailability when BI 661051 is administered as oral drinking solution after intake of a high fat meal. Pharmacodynamic parameters will not be determined within this study.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• Occurrence of findings of physical examination

  14 weeks

• Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate [RR])

  14 weeks

• Orthostasis test parameters

  14 weeks

• Body temperature

  14 weeks

• 12-lead electrocardiogram (ECG) parameters (heart rate, PQ interval, QRS interval, uncorrected QT interval as well as Bazett- and Fridericia corrected QT interval)

  14 weeks

• Clinical laboratory test parameters (haematology, clinical chemistry and urinalysis parameters)

  14 weeks

• Occurrence of adverse events (AEs) on the level of Medical Dictionary for Regulatory Affairs (MedDRA) Preferred Terms and MedDRA System Organ Class

  14 weeks

• Occurrence of findings detected by the pupillometry measurements

  14 weeks

• Tolerability assessed by investigator

  14 weeks

Secondary Outcomes (4)

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

  14 weeks

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

  14 weeks

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

  14 weeks

• Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)

  14 weeks

Study Arms (11)

BI 661051 low dose, low

EXPERIMENTAL

solution for oral administration, single dose

Drug: BI 661051

BI 661051 low dose, medium

EXPERIMENTAL

solution for oral administration, single dose

Drug: BI 661051

BI 661051 low dose, high

EXPERIMENTAL

solution for oral administration, single dose

Drug: BI 661051

BI 661051 medium dose, low

EXPERIMENTAL

solution for oral administration, single dose

Drug: BI 661051

BI 661051 medium dose, medium

EXPERIMENTAL

solution for oral administration, single dose

Drug: BI 661051

BI 661051 medium dose, high

EXPERIMENTAL

solution for oral administration, single dose

Drug: BI 661051

BI 661051 high dose, low

EXPERIMENTAL

solution for oral administration, single dose

Drug: BI 661051

BI 661051 high dose, medium

EXPERIMENTAL

solution for oral administration, single dose

Drug: BI 661051

BI 661051 low dose

EXPERIMENTAL

tablet

Drug: BI 661051

BI 661051 medium dose

EXPERIMENTAL

tablet

Drug: BI 661051

Placebo

PLACEBO COMPARATOR

solution for oral administratrion

Drug: Placebo

Interventions

BI 661051 DRUG

medium dose solution for oral administration

BI 661051 medium dose, low

Placebo DRUG

solution for administration

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy males based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests. There is no finding deviating from normal and of clinical relevance. There is no evidence of a clinically relevant concomitant disease.
• Age =18 and age =50 years.
• BMI =18.5 and BMI =30 kg/m2 (Body Mass Index).
• Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

You may not qualify if:

• Any finding of the medical examination (including BP, PR and ECG) 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.
• 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 to drug or its excipients) as judged clinically relevant by the investigator.
• Intake of drugs with a long half-life (\>24 h) 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 based on the knowledge at the time of protocol preparation within 10 days prior to randomisation.
• Participation in another trial with an investigational drug within 30 days prior to randomisation.
• Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day).
• Inability to refrain from smoking on trial days as judged by the investigator.
• Alcohol abuse (more than 30 g/day).
• Drug abuse.
• Blood donation (more than 100 mL within 4 weeks prior to randomisation or during the trial).

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1296.1.1 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: April 28, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2011
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

DE (1)