Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers
Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Completed
CT.gov ID
NCT01594515
Collaborator
(none)
70
1
10
4
17.3
Study Details
Study Description
Brief Summary
In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers (a Partially Randomised, Partially Single-blind, Placebo-controlled Phase I Study)
Study Start Date
:
May 1, 2012
Actual Primary Completion Date
:
Sep 1, 2012
Actual Study Completion Date
:
Sep 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BI 1015550 low dose A Powder for oral solution |
Drug: BI 1015550
Low dose powder for oral solution
|
| Experimental: BI 1015550 low dose B Powder for oral solution |
Drug: BI 1015550
Low dose powder for oral solution
|
| Experimental: BI 1015550 low dose C Powder for oral solution |
Drug: BI 1015550
Low dose powder for oral solution
|
| Experimental: BI 1015550 low dose D Powder for oral solution |
Drug: BI 1015550
Low dose powder for oral solution
|
| Experimental: BI 1015550 medium dose A Powder for oral solution |
Drug: BI 1015550
Medium dose powder for oral solution
|
| Experimental: BI 1015550 medium dose B Powder for oral solution |
Drug: BI 1015550
Medium dose powder for oral solution
|
| Experimental: BI 1015550 medium dose C Powder for oral solution |
Drug: BI 1015550
Medium dose powder for oral solution
|
| Experimental: BI 1015550 high dose A Powder for oral solution |
Drug: BI 1015550
High dose powder for oral solution
|
| Experimental: BI 1015550 high dose B Powder for oral solution |
Drug: BI 101550
High dose powder for oral solution
|
| Placebo Comparator: Placebo Solution for oral administration |
Drug: Placebo
Solution for oral administration
|
Outcome Measures
Primary Outcome Measures
- Number (%) of Subjects With Drug Related Adverse Events [From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.]
Percentage of subjects with drug related adverse events.
- Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests [Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).]
Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).
- Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs [Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).]
Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).
- Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs [Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).]
Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.
- Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability [From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.]
Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.
- Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations [From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days.]
Percentage of subjects with clinically relevant abnormalities in physical examinations.
Secondary Outcome Measures
- Cmax of BI 1015550 [-0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing]
Maximum measured concentration of the analyte in plasma.
- AUC0-infinity of BI 1015550 [-0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing]
Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion criteria:
- Healthy male subjects
Exclusion criteria:
- Any relevant deviation from healthy conditions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 1305.1.1 Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
Sponsors and Collaborators
- Boehringer Ingelheim
Investigators
- Study Chair: Boehringer Ingelheim, Boehringer Ingelheim
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01594515
Other Study ID Numbers:
- 1305.1
- 2012-000405-68
First Posted:
May 9, 2012
Last Update Posted:
Dec 15, 2015
Last Verified:
Nov 1, 2015
Study Results
Participant Flow
| Recruitment Details | 70 patients were treated and analysed. |
|---|---|
| Pre-assignment Detail | Partially randomised, placebo-controlled within dose groups, single-blinded, single-centre study to assess the safety, tolerability and pk of single rising oral doses of BI 1015550(a powder for oral solution reconstituted with solvent tartaric acid and solvent component hydroxy-propyl-β-cyclodextrin (HPβCD)) in healthy male volunteers. |
| Arm/Group Title | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
| Period Title: Overall Study | ||||||||||
| STARTED | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 16 |
| COMPLETED | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 16 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. | Total of all reporting groups |
| Overall Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 16 | 70 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||||||
| Mean (Standard Deviation) [Years] |
33.5
(5.1)
|
29.5
(4.8)
|
38.2
(6.5)
|
35.0
(5.5)
|
35.5
(5.9)
|
32.7
(5.9)
|
36.3
(6.3)
|
40.5
(3.3)
|
33.5
(8.4)
|
36.6
(5.6)
|
35.3
(6.1)
|
| Sex: Female, Male (Count of Participants) | |||||||||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
16
100%
|
70
100%
|
Outcome Measures
| Title | Number (%) of Subjects With Drug Related Adverse Events |
|---|---|
| Description | Percentage of subjects with drug related adverse events. |
| Time Frame | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. |
| Arm/Group Title | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 16 |
| Number [Percentage of Participants] |
0.0
0%
|
33.3
555%
|
16.7
278.3%
|
0.0
0%
|
0.0
0%
|
33.3
555%
|
16.7
278.3%
|
16.7
278.3%
|
16.7
278.3%
|
6.3
39.4%
|
| Title | Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests |
|---|---|
| Description | Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis). |
| Time Frame | Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). |
Outcome Measure Data
| Analysis Population Description |
|---|
| The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. |
| Arm/Group Title | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 16 |
| Number [Percentage of Participants] |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Title | Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs |
|---|---|
| Description | Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test). |
| Time Frame | Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). |
Outcome Measure Data
| Analysis Population Description |
|---|
| The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. |
| Arm/Group Title | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 16 |
| Number [Percentage of Participants] |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Title | Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs |
|---|---|
| Description | Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs. |
| Time Frame | Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). |
Outcome Measure Data
| Analysis Population Description |
|---|
| The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. |
| Arm/Group Title | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 16 |
| Number [Percentage of Participants] |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Title | Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability |
|---|---|
| Description | Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator. |
| Time Frame | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. |
| Arm/Group Title | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 16 |
| Number [Percentage of Participants] |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Title | Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations |
|---|---|
| Description | Percentage of subjects with clinically relevant abnormalities in physical examinations. |
| Time Frame | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The treated set (TS) included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of the investigational treatment. |
| Arm/Group Title | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 16 |
| Number [Percentage of Participants] |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Title | Cmax of BI 1015550 |
|---|---|
| Description | Maximum measured concentration of the analyte in plasma. |
| Time Frame | -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing |
Outcome Measure Data
| Analysis Population Description |
|---|
| The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation. |
| Arm/Group Title | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [nmol/L] |
NA
(NA)
|
1.42
(23.2)
|
5.02
(20.1)
|
13.7
(14.2)
|
46.9
(38.9)
|
113
(20.4)
|
176
(12.6)
|
292
(22.2)
|
542
(12.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BI 1015550 Low Dose 0.06mg, BI 1015550 Low Dose 0.2mg, BI 1015550 Low Dose 0.6mg, BI 1015550 Medium Dose 2mg, BI 1015550 Medium Dose 4mg, BI 1015550 Medium Dose 8mg, BI 1015550 High Dose 16mg, BI 1015550 High Dose 24mg |
|---|---|---|
| Comments | This was non confirmatory testing (Single dose). Dose proportionality of the drug for Cmax was analysed.(N=50) | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 0.9702 | |
| Confidence Interval |
(2-Sided) 95% 0.9400 to 1.0005 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0151 |
|
| Estimation Comments | Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. | |
| Title | AUC0-infinity of BI 1015550 |
|---|---|
| Description | Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity |
| Time Frame | -0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing |
Outcome Measure Data
| Analysis Population Description |
|---|
| The pharmacokinetic analysis set (PKS) included all subjects in the TS who provided at least 1 evaluable observation for a PK endpoint. A subject was considered to be evaluable if he provided sufficient data, did not vomit at or before 2x median tmax and completed the trial without any iPV relevant to the PK evaluation. |
| Arm/Group Title | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [nmol*h/L] |
NA
(NA)
|
7.44
(12.7)
|
24.1
(13.9)
|
67.9
(15.6)
|
287
(14.9)
|
679
(32.0)
|
1210
(18.3)
|
2180
(19.9)
|
3650
(22.6)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | BI 1015550 Low Dose 0.06mg, BI 1015550 Low Dose 0.2mg, BI 1015550 Low Dose 0.6mg, BI 1015550 Medium Dose 2mg, BI 1015550 Medium Dose 4mg, BI 1015550 Medium Dose 8mg, BI 1015550 High Dose 16mg, BI 1015550 High Dose 24mg |
|---|---|---|
| Comments | This was non confirmatory testing (Single dose). Dose proportionality of the drug for AUC0-inf was analysed. (N=48) | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Slope |
| Estimated Value | 1.0442 | |
| Confidence Interval |
(2-Sided) 95% 1.0145 to 1.0740 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0148 |
|
| Estimation Comments | Dose proportionality was explored using the power model (ANCOVA). The perfect dose proportionality would correspond to a slope β of 1. PK endpoints on the log-transformed scale. | |
Adverse Events
| Time Frame | From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||
| Arm/Group Title | Placebo | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | ||||||||||
| Arm/Group Description | Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers. | ||||||||||
All Cause Mortality |
||||||||||||||||||||
| Placebo | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||
Serious Adverse Events |
||||||||||||||||||||
| Placebo | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||
| Placebo | BI 1015550 Low Dose 0.02mg | BI 1015550 Low Dose 0.06mg | BI 1015550 Low Dose 0.2mg | BI 1015550 Low Dose 0.6mg | BI 1015550 Medium Dose 2mg | BI 1015550 Medium Dose 4mg | BI 1015550 Medium Dose 8mg | BI 1015550 High Dose 16mg | BI 1015550 High Dose 24mg | |||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/16 (31.3%) | 2/6 (33.3%) | 2/6 (33.3%) | 3/6 (50%) | 3/6 (50%) | 1/6 (16.7%) | 3/6 (50%) | 3/6 (50%) | 2/6 (33.3%) | 3/6 (50%) | ||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||
| Ear discomfort | 0/16 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||
| Abdominal pain | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||||||
| Diarrhoea | 1/16 (6.3%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| Lip dry | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| Nausea | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| Vomiting | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| General disorders | ||||||||||||||||||||
| Application site irritation | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/6 (0%) | ||||||||||
| Fatigue | 0/16 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| Infections and infestations | ||||||||||||||||||||
| Nasopharyngitis | 2/16 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| Oral herpes | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||
| Rhinitis | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||
| Sinusitis | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||
| Accident | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||
| Arthropod bite | 0/16 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| Contusion | 1/16 (6.3%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| Excoriation | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||
| Back pain | 0/16 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| Nervous system disorders | ||||||||||||||||||||
| Headache | 1/16 (6.3%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/6 (16.7%) | 2/6 (33.3%) | 2/6 (33.3%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||
| Cough | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||||||
| Oropharyngeal pain | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||
| Dermatitis | 0/16 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | ||||||||||
Limitations/Caveats
BI 1015550 high dose 24mg was originally planned as 26 mg but reduced due to PK interim analysis results of previous dose group.
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Boehringer Ingelheim, Call Center |
|---|---|
| Organization | Boehringer Ingelheim |
| Phone | 1-800-243-0127 |
| clintriage.rdg@boehringer-ingelheim.com |
Responsible Party:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01594515
Other Study ID Numbers:
- 1305.1
- 2012-000405-68
First Posted:
May 9, 2012
Last Update Posted:
Dec 15, 2015
Last Verified:
Nov 1, 2015