We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01681277
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 113608 PIB bid Drug: Placebo to BI 113608 PIB bid Drug: Placebo to BI 113608 PIB qd Drug: BI 113608 PIB qd Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d. for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)
Study Start Date : September 2012
Primary Completion Date : May 2013
Study Completion Date : May 2013
Arms and Interventions

Arm Intervention/treatment
Experimental: BI 113608 high dose bid
powder in the bottle for oral solution, oral administration with 240 ml water
Drug: Placebo to BI 113608 PIB bid
powder for oral solution
Drug: BI 113608 PIB bid
powder for oral solution
Experimental: BI 113608 low dose bid
powder in the bottle for oral solution, oral administration with 240 ml water
Drug: Placebo to BI 113608 PIB bid
powder for oral solution
Drug: BI 113608 PIB bid
powder for oral solution
Experimental: BI 113608 medium dose bid
powder in the bottle for oral solution, oral administration with 240 ml water
Drug: BI 113608 PIB bid
powder for oral solution
Drug: Placebo to BI 113608 PIB bid
powder for oral solution
Experimental: BI 113608 high dose qd
powder in the bottle for oral solution, oral administration with 240 ml water
Drug: Placebo to BI 113608 PIB qd
powder for oral solution
Drug: BI 113608 PIB qd
powder for oral solution


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Participants With Drug-related Adverse Events [ Time Frame: From administration of study drug until end-of-study, up to 17 days ]
    Percentage of participants with drug-related adverse events

  2. Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings [ Time Frame: 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 :
  1. Cmax,ss [ Time Frame: 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).

  2. Tmax,ss [ Time Frame: 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).

  3. AUCtau,ss [ Time Frame: 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).

  4. t1/2,ss [ Time Frame: 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).

  5. RA,Cmax [ Time Frame: -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).

  6. RA,AUC [ Time Frame: -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).


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681277


Locations
Germany
Boehringer Ingelheim Investigational Site
Mannheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01681277     History of Changes
Other Study ID Numbers: 1314.2
2012-002536-82 ( EudraCT Number: EudraCT )
First Posted: September 7, 2012    Key Record Dates
Results First Posted: January 20, 2017
Last Update Posted: January 20, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Pharmaceutical Solutions