NCT01835899

Brief Summary

To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2013

Shorter than P25 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

April 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

January 22, 2016

Completed
Last Updated

January 22, 2016

Status Verified

December 1, 2015

Enrollment Period

2 months

First QC Date

April 9, 2013

Results QC Date

November 11, 2015

Last Update Submit

December 16, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Subjects With Drug-related Adverse Events

    Percentage of subjects with drug related Adverse events, as assessed by the investigator.

    From first drug administration until last drug administration, upto 18 days.

Secondary Outcomes (5)

  • Cmax

    0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.

  • AUCt,1

    0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration

  • AUC0-infinity

    0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration.

  • Cmax,ss

    311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h.

  • AUCt,ss

    311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h.

Study Arms (5)

Placebo to BI 1015550

EXPERIMENTAL

placebo

Drug: Placebo

BI 1015550 low dose 1

EXPERIMENTAL

powder for oral solution

Drug: BI 1015550

BI 1015550 low dose 2

EXPERIMENTAL

powder for oral solution

Drug: BI1015550

BI 1015550 medium dose 1

EXPERIMENTAL

powder for oral solution

Drug: BI 1015550

BI 1015550 medium dose 2

EXPERIMENTAL

powder for oral solution

Drug: BI 1015550

Interventions

PlaceboDRUG

Placebo to BI 1015550

Placebo to BI 1015550
BI 1015550DRUG

medium dose 1 powder for oral solution

BI 1015550 medium dose 1
BI1015550DRUG

low dose 2 powder for oral solution

BI 1015550 low dose 2

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
  • Subjects unable to understand or to comply with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1305.2.1 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

MeSH Terms

Interventions

BI 1015550

Limitations and Caveats

The study was prematurely completed as per protocol after 2 of the originally planned 4 dose groups ie., 1 mg BI 1015550 and 6 mg BI 1015550 because of higher than expected drug exposure.

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

April 9, 2013

First Posted

April 19, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 22, 2016

Results First Posted

January 22, 2016

Record last verified: 2015-12

Locations

DE(1)