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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 661051; Drug: Placebo

• Registration Number: NCT01343719
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Purpose:

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-19
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-28
• Primary Completion: 2011-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 661051 medium dose, low	BI 661051	solution for oral administration, single dose
BI 661051 medium dose, medium	BI 661051	solution for oral administration, single dose
BI 661051 medium dose, high	BI 661051	solution for oral administration, single dose
BI 661051 high dose, low	BI 661051	solution for oral administration, single dose
BI 661051 high dose, medium	BI 661051	solution for oral administration, single dose
BI 661051 low dose	BI 661051	tablet
BI 661051 medium dose	BI 661051	tablet
Placebo	Placebo	solution for oral administratrion
BI 661051 low dose, low	BI 661051	solution for oral administration, single dose
BI 661051 low dose, medium	BI 661051	solution for oral administration, single dose
BI 661051 low dose, high	BI 661051	solution for oral administration, single dose

Primary Outcome Measures

Name	Time	Method
Orthostasis test parameters	14 weeks
Occurrence of findings of physical examination	14 weeks
Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate [RR])	14 weeks
Body temperature	14 weeks
Clinical laboratory test parameters (haematology, clinical chemistry and urinalysis parameters)	14 weeks
Occurrence of findings detected by the pupillometry measurements	14 weeks
Tolerability assessed by investigator	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
Occurrence of adverse events (AEs) on the level of Medical Dictionary for Regulatory Affairs (MedDRA) Preferred Terms and MedDRA System Organ Class	14 weeks

Secondary Outcome Measures

Name	Time	Method
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
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	14 weeks
Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)	14 weeks
Cmax (maximum measured concentration of the analyte in plasma)	14 weeks

Trial Locations

Locations (1)

1296.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany