NCT01540825

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2012

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

February 1, 2012

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
4.7 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

3 months

First QC Date

February 13, 2012

Results QC Date

November 23, 2016

Last Update Submit

November 23, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • 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

  • 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

    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

    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

    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

Study Arms (11)

BI 113608 high dose 1

EXPERIMENTAL

Powder for oral solution

Drug: BI 113608

BI 113608 low dose 1

EXPERIMENTAL

Powder for oral solution

Drug: BI 113608

BI 113608 low dose 2

EXPERIMENTAL

Powder for oral solution

Drug: BI 113608

BI 113608 low dose 4

EXPERIMENTAL

Powder for oral solution

Drug: BI 113608

BI 113608 low dose 5

EXPERIMENTAL

Powder for oral solution

Drug: BI 113608

BI 113608 medium dose 1

EXPERIMENTAL

Powder for oral solution

Drug: BI 113608

BI 113608 medium dose 2

EXPERIMENTAL

Powder for oral solution

Drug: BI 113608

BI 113608 medium dose 3

EXPERIMENTAL

Powder for oral solution

Drug: BI 113608

BI 113608 high dose 2

EXPERIMENTAL

Powder for oral solution

Drug: BI 113608

BI 113608 high dose 3

EXPERIMENTAL

Powder for oral solution

Drug: BI 113608

Placebo

PLACEBO COMPARATOR

Powder for oral solution

Drug: Placebo

Interventions

BI 113608DRUG

Low dose powder for oral solution

BI 113608 low dose 1
PlaceboDRUG

Powder for oral solution

Placebo

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 29, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 20, 2017

Results First Posted

January 20, 2017

Record last verified: 2016-11

Locations

DE(1)