First in Man Trial of BI 113608

Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113608 in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BI 113608; Drug: BI 113608; Drug: BI 113608

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Mannheim, Germany
    • Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 113608 high dose 1; Powder for oral solution	Drug: BI 113608; Low dose powder for oral solution; Drug: BI 113608; High dose powder for oral solution; Drug: BI 113608; Medium dose powder for oral solution
Experimental: BI 113608 low dose 1; Powder for oral solution	Drug: BI 113608; Low dose powder for oral solution; Drug: BI 113608; High dose powder for oral solution; Drug: BI 113608; Medium dose powder for oral solution
Experimental: BI 113608 low dose 2; Powder for oral solution	Drug: BI 113608; Low dose powder for oral solution; Drug: BI 113608; High dose powder for oral solution; Drug: BI 113608; Medium dose powder for oral solution
Experimental: BI 113608 low dose 4; Powder for oral solution	Drug: BI 113608; Low dose powder for oral solution; Drug: BI 113608; High dose powder for oral solution; Drug: BI 113608; Medium dose powder for oral solution
Experimental: BI 113608 low dose 5; Powder for oral solution	Drug: BI 113608; Low dose powder for oral solution; Drug: BI 113608; High dose powder for oral solution; Drug: BI 113608; Medium dose powder for oral solution
Experimental: BI 113608 medium dose 1; Powder for oral solution	Drug: BI 113608; Low dose powder for oral solution; Drug: BI 113608; High dose powder for oral solution; Drug: BI 113608; Medium dose powder for oral solution
Experimental: BI 113608 medium dose 2; Powder for oral solution	Drug: BI 113608; Low dose powder for oral solution; Drug: BI 113608; High dose powder for oral solution; Drug: BI 113608; Medium dose powder for oral solution
Experimental: BI 113608 medium dose 3; Powder for oral solution	Drug: BI 113608; Low dose powder for oral solution; Drug: BI 113608; High dose powder for oral solution; Drug: BI 113608; Medium dose powder for oral solution
Experimental: BI 113608 high dose 2; Powder for oral solution	Drug: BI 113608; Low dose powder for oral solution; Drug: BI 113608; High dose powder for oral solution; Drug: BI 113608; Medium dose powder for oral solution
Experimental: BI 113608 high dose 3; Powder for oral solution	Drug: BI 113608; Low dose powder for oral solution; Drug: BI 113608; High dose powder for oral solution; Drug: BI 113608; Medium dose powder for oral solution
Placebo Comparator: Placebo; Powder for oral solution	Drug: Placebo; Powder for oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	From administration of study drug until end-of-study visit, up to 10 days
Percentage of Participants With Drug-related Adverse Events	Percentage of participants with drug-related adverse events	From administration of study drug until end-of-study visit, up to 10 days
Assessment of Tolerability by the Investigator	Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.	End of study visit, up to day 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	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.	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
Tmax	Time from dosing to maximum measured concentration of the analyte in plasma (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
AUC0-tz	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)	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
AUC0-infinity	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (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
t1/2	Terminal half-life of the analyte in plasma (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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: February 23, 2012
• First Posted (Estimate): February 29, 2012

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 1314.1; 2011-005034-19 (EudraCT Number: EudraCT)