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)

In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: BI 1015550; Drug: BI 1015550; Drug: BI 1015550; Drug: BI 101550

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Ingelheim, Germany
    • 1305.1.1 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Solution for oral administration	Drug: Placebo; Solution for oral administration
Experimental: BI 1015550 low dose A; Powder for oral solution	Drug: BI 1015550; High dose powder for oral solution; Drug: BI 1015550; Medium dose 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; High dose powder for oral solution; Drug: BI 1015550; Medium dose 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; High dose powder for oral solution; Drug: BI 1015550; Medium dose 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; High dose powder for oral solution; Drug: BI 1015550; Medium dose 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; High dose powder for oral solution; Drug: BI 1015550; Medium dose powder for oral solution; Drug: BI 1015550; Low dose powder for oral solution
Experimental: BI 1015550 medium dose B; Powder for oral solution	Drug: BI 1015550; High dose powder for oral solution; Drug: BI 1015550; Medium dose powder for oral solution; Drug: BI 1015550; Low dose powder for oral solution
Experimental: BI 1015550 medium dose C; Powder for oral solution	Drug: BI 1015550; High dose powder for oral solution; Drug: BI 1015550; Medium dose powder for oral solution; Drug: BI 1015550; Low dose powder for oral solution
Experimental: BI 1015550 high dose A; Powder for oral solution	Drug: BI 1015550; High dose powder for oral solution; Drug: BI 1015550; Medium dose powder for oral solution; Drug: BI 1015550; Low dose powder for oral solution
Experimental: BI 1015550 high dose B; Powder for oral solution	Drug: BI 101550; High dose powder for oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number (%) of Subjects With Drug Related Adverse Events	Percentage 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.
Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests	Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).	Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling).
Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs	Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).	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).
Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs	Percentage 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).
Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability	Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.	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.
Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations	Percentage 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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of BI 1015550	Maximum measured concentration of the analyte in plasma.	-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
AUC0-infinity of BI 1015550	Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity	-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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: May 7, 2012
• First Submitted That Met QC Criteria: May 8, 2012
• First Posted (Estimate): May 9, 2012

Study Record Updates

• Last Update Posted (Estimate): December 15, 2015
• Last Update Submitted That Met QC Criteria: November 11, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 1305.1; 2012-000405-68 (EudraCT Number: EudraCT)