NCT01681277

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2012

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed
Last Updated

January 20, 2017

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

September 5, 2012

Results QC Date

November 23, 2016

Last Update Submit

November 23, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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, up to 17 days

  • Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings

    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)

    From administration of study drug until end-of-study, up to 17 days

Secondary Outcomes (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • +1 more secondary outcomes

Study Arms (4)

BI 113608 high dose bid

EXPERIMENTAL

powder in the bottle for oral solution, oral administration with 240 ml water

Drug: Placebo to BI 113608 PIB bidDrug: BI 113608 PIB bid

BI 113608 low dose bid

EXPERIMENTAL

powder in the bottle for oral solution, oral administration with 240 ml water

Drug: Placebo to BI 113608 PIB bidDrug: BI 113608 PIB bid

BI 113608 medium dose bid

EXPERIMENTAL

powder in the bottle for oral solution, oral administration with 240 ml water

Drug: BI 113608 PIB bidDrug: Placebo to BI 113608 PIB bid

BI 113608 high dose qd

EXPERIMENTAL

powder in the bottle for oral solution, oral administration with 240 ml water

Drug: Placebo to BI 113608 PIB qdDrug: BI 113608 PIB qd

Interventions

BI 113608 PIB bidDRUG

powder for oral solution

BI 113608 medium dose bid
Placebo to BI 113608 PIB bidDRUG

powder for oral solution

BI 113608 low dose bid
Placebo to BI 113608 PIB qdDRUG

powder for oral solution

BI 113608 high dose qd
BI 113608 PIB qdDRUG

powder for oral solution

BI 113608 high dose qd

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. healthy male subjects

You may not qualify if:

  • \. Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

Results Point of Contact

Title
Boehringer Ingelheim, Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 7, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 20, 2017

Results First Posted

January 20, 2017

Record last verified: 2016-11

Locations

DE(1)