Safety of Single Rising Doses and Relative Bioavailability of BI 691751

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 691751; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01843972

1334.1

2012-005721-67 (EudraCT Number)

Details and patient eligibility

About

To investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of single rising doses of BI 691751 in healthy male subjects (part I).

To investigate the relative bioavailability of BI 691751 given as tablet versus oral solution (part II)

Enrollment: 81 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male subjects
2. Subjects must be able to understand and comply with study requirements
3. Age from 18 to 55 years
4. BMI range: from 18.5 to 29.9 kg/m2
5. Known genotype as specified in the study protocol

Exclusion criteria

1. Any relevant deviation from healthy conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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81 participants in 10 patient groups, including a placebo group

BI 691751 dose 2 (part I)

Experimental group

Description:

single dose given as oral solution

Treatment:

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

BI 691751 dose 3 (part I)

Experimental group

Description:

single dose given as oral solution

Treatment:

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

BI 691751 dose 4 (part I)

Experimental group

Description:

single dose given as oral solution

Treatment:

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

BI 691751 dose 5 (part I)

Experimental group

Description:

single dose given as oral solution

Treatment:

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

BI 691751 dose 6 (part I)

Experimental group

Description:

single dose given as oral solution

Treatment:

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

BI 691751 dose 7 (part I)

Experimental group

Description:

single dose given as oral solution

Treatment:

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

BI 691751dose 1 (part I)

Experimental group

Description:

single dose given as oral solution

Treatment:

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Placebo (part I)

Placebo Comparator group

Description:

placebo solution

Treatment:

Drug: Placebo

BI 691751 tablet (part II)

Experimental group

Description:

single dose given as 1 tablet

Treatment:

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

BI 691751 solution (part II)

Active Comparator group

Description:

single dose given as oral solution

Treatment:

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751

Drug: BI 691751