First in Man Trial of BI 113608

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 113608; Drug: Placebo

• Registration Number: NCT01540825
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-23
• Study First Posted: 2012-02-29
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-11
• Results First Submitted: 2016-11-23
• Results First Submitted QC: 2016-11-23
• Last Update Submitted: 2016-11-23
• Results First Posted: 2017-01-20
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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 113608 medium dose 1	BI 113608	Powder for oral solution
BI 113608 medium dose 2	BI 113608	Powder for oral solution
BI 113608 medium dose 3	BI 113608	Powder for oral solution
BI 113608 high dose 2	BI 113608	Powder for oral solution
BI 113608 high dose 3	BI 113608	Powder for oral solution
Placebo	Placebo	Powder for oral solution
BI 113608 high dose 1	BI 113608	Powder for oral solution
BI 113608 low dose 1	BI 113608	Powder for oral solution
BI 113608 low dose 2	BI 113608	Powder for oral solution
BI 113608 low dose 4	BI 113608	Powder for oral solution
BI 113608 low dose 5	BI 113608	Powder for oral solution

Primary Outcome Measures

Name	Time	Method
Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test	From administration of study drug until end-of-study visit, up to 10 days	Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test
Percentage of Participants With Drug-related Adverse Events	From administration of study drug until end-of-study visit, up to 10 days	Percentage of participants with drug-related adverse events
Assessment of Tolerability by the Investigator	End of study visit, up to day 10	Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.

Secondary Outcome Measures

Name	Time	Method
AUC0-tz	Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz)
AUC0-infinity	Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity)
Tmax	Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration	Time from dosing to maximum measured concentration of the analyte in plasma (Tmax)
Cmax	Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration	Maximum measured concentration of the analyte in plasma (Cmax).; The analysis population was the pharmacokinetic (PK) set which included all subjects randomised and treated with study medication who provided at least 1 evaluable observation for a PK endpoint of Area Under the Concentration-time Curve from 0 to infinity (AUC0-inf), Area Under the Concentration-time Curve from 0 to the last quantifiable data point (AUC0-tz) and Cmax and who had no important protocol violations relevant to the evaluation of PK.
t1/2	Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration	Terminal half-life of the analyte in plasma (t1/2)

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany