Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo to BI 113608 PIB bid; Drug: Placebo to BI 113608 PIB qd; Drug: BI 113608 PIB bid; Drug: BI 113608 PIB qd

• Registration Number: NCT01681277
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-07
• Primary Completion: 2013-05
• Study Completion: 2013-05
• 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: 48

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 113608 high dose bid	Placebo to BI 113608 PIB bid	powder in the bottle for oral solution, oral administration with 240 ml water
BI 113608 high dose bid	BI 113608 PIB bid	powder in the bottle for oral solution, oral administration with 240 ml water
BI 113608 low dose bid	Placebo to BI 113608 PIB bid	powder in the bottle for oral solution, oral administration with 240 ml water
BI 113608 low dose bid	BI 113608 PIB bid	powder in the bottle for oral solution, oral administration with 240 ml water
BI 113608 medium dose bid	BI 113608 PIB bid	powder in the bottle for oral solution, oral administration with 240 ml water
BI 113608 medium dose bid	Placebo to BI 113608 PIB bid	powder in the bottle for oral solution, oral administration with 240 ml water
BI 113608 high dose qd	Placebo to BI 113608 PIB qd	powder in the bottle for oral solution, oral administration with 240 ml water
BI 113608 high dose qd	BI 113608 PIB qd	powder in the bottle for oral solution, oral administration with 240 ml water

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Drug-related Adverse Events	From administration of study drug until end-of-study, up to 17 days	Percentage of participants with drug-related adverse events
Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings	From administration of study drug until end-of-study, up to 17 days	Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)

Secondary Outcome Measures

Name	Time	Method
Cmax,ss	311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.	Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss).
Tmax,ss	311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.	Time from last dosing to maximum concentration of the analyte in plasma at steady state (tmax,ss).
AUCtau,ss	311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.	Area under the concentration-time curve of the analyte BI 113608 in plasma at steady state over a uniform dosing interval t (AUCtau,ss).
t1/2,ss	311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.	Terminal half-life of the analyte in plasma at steady state (t1/2,ss).
RA,Cmax	-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.	Accumulation ratio of the analyte in plasma at steady state after multiple oral administration over a uniform dosing interval t, expressed as ratio of Cmax at steady state and after single dose (RA,Cmax).
RA,AUC	-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.	Accumulation ratio of the analyte in plasma at steady state after multiple dose administration over a uniform dosing interval t, expressed as ratio of AUC at steady state and after single dose (RA,AUC).

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇩🇪 Mannheim, Germany