Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01594515

Enrollment

Registered

2012-05-09

Start date

2012-05-31

Completion date

2012-09-30

Last updated

2015-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGBI 1015550

High dose powder for oral solution

DRUGPlacebo

Solution for oral administration

DRUGBI 101550

High dose powder for oral solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1\. Healthy male subjects

Exclusion criteria

1\. Any relevant deviation from healthy conditions

Design outcomes

Primary

Measure	Time frame	Description
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.
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 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).

Secondary

Measure	Time frame	Description
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
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.

Countries

Germany

Participant flow

Recruitment details

70 patients were treated and analysed.

Pre-assignment details

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.

Participants by arm

Arm	Count
BI 1015550 Low Dose 0.02mg Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.	6
BI 1015550 Low Dose 0.06mg Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.	6
BI 1015550 Low Dose 0.2mg Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.	6
BI 1015550 Low Dose 0.6mg Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.	6
BI 1015550 Medium Dose 2mg Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.	6
BI 1015550 Medium Dose 4mg Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.	6
BI 1015550 Medium Dose 8mg Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.	6
BI 1015550 High Dose 16mg Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.	6
BI 1015550 High Dose 24mg Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.	6
Placebo Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.	16
Total	70

Baseline characteristics

Characteristic	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
Age, Continuous	33.5 Years STANDARD_DEVIATION 5.1	29.5 Years STANDARD_DEVIATION 4.8	38.2 Years STANDARD_DEVIATION 6.5	35.0 Years STANDARD_DEVIATION 5.5	35.5 Years STANDARD_DEVIATION 5.9	32.7 Years STANDARD_DEVIATION 5.9	36.3 Years STANDARD_DEVIATION 6.3	40.5 Years STANDARD_DEVIATION 3.3	33.5 Years STANDARD_DEVIATION 8.4	36.6 Years STANDARD_DEVIATION 5.6	35.3 Years STANDARD_DEVIATION 6.1
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	16 Participants	70 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	5 / 16	2 / 6	2 / 6	3 / 6	3 / 6	1 / 6	3 / 6	3 / 6	2 / 6	3 / 6
serious Total, serious adverse events	0 / 16	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6	0 / 6

Outcome results

Primary

Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs

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).