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

• ClinicalTrials.gov Identifier: NCT01594515
• Recruitment Status: Completed
• First Posted: May 9, 2012
• Results First Posted: December 15, 2015
• Last Update Posted: December 15, 2015
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

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
Healthy	Drug: BI 1015550; Drug: Placebo; Drug: BI 101550	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• 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 2012
• Actual Primary Completion Date: September 2012
• Actual Study Completion Date: September 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 :

1. Number (%) 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. ]
   Percentage of subjects with drug related adverse events.
2. Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests [ 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). ]
   Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).
3. Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs [ 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). ]
   Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).
4. Number (%) 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). ]
   Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.
5. Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability [ 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. ]
   Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.
6. Number (%) 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. ]
   Percentage of subjects with clinically relevant abnormalities in physical examinations.

Secondary Outcome Measures :

1. Cmax of BI 1015550 [ 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 ]
   Maximum measured concentration of the analyte in plasma.
2. AUC0-infinity of BI 1015550 [ 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 ]
   Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Contacts and Locations

Locations

Germany

1305.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT01594515
• Other Study ID Numbers: 1305.1; 2012-000405-68 ( EudraCT Number: EudraCT )
• First Posted: May 9, 2012
• Results First Posted: December 15, 2015
• Last Update Posted: December 15, 2015
• Last Verified: November 2015