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

NCT01594515 | Completed Phase 1 Results

• 2 other identifiers: 1305.12012-000405-68
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• 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

• 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

Study Arms (10)

BI 1015550 low dose A

EXPERIMENTAL

Powder for oral solution

Drug: BI 1015550

BI 1015550 low dose B

EXPERIMENTAL

Powder for oral solution

Drug: BI 1015550

BI 1015550 low dose C

EXPERIMENTAL

Powder for oral solution

Drug: BI 1015550

BI 1015550 low dose D

EXPERIMENTAL

Powder for oral solution

Drug: BI 1015550

BI 1015550 medium dose A

EXPERIMENTAL

Powder for oral solution

Drug: BI 1015550

BI 1015550 medium dose B

EXPERIMENTAL

Powder for oral solution

Drug: BI 1015550

BI 1015550 medium dose C

EXPERIMENTAL

Powder for oral solution

Drug: BI 1015550

BI 1015550 high dose A

EXPERIMENTAL

Powder for oral solution

Drug: BI 1015550

BI 1015550 high dose B

EXPERIMENTAL

Powder for oral solution

Drug: BI 101550

Placebo

PLACEBO COMPARATOR

Solution for oral administration

Drug: Placebo

Interventions

BI 1015550 DRUG

High dose powder for oral solution

BI 1015550 high dose A

Placebo DRUG

Solution for oral administration

Placebo

BI 101550 DRUG

High dose powder for oral solution

BI 1015550 high dose B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy male subjects

You may not qualify if:

• \. Any relevant deviation from healthy conditions

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1305.1.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

MeSH Terms

Interventions

BI 1015550

Limitations and Caveats

BI 1015550 high dose 24mg was originally planned as 26 mg but reduced due to PK interim analysis results of previous dose group.

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: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 9, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: December 15, 2015
• Results First Posted: December 15, 2015

Record last verified: 2015-11

Locations

DE (1)