Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo to BI 1021958; Drug: BI 1021958

Study type: Interventional

Funder types: Industry

Identifiers

NCT01541488

1310.1

2011-003483-70 (EudraCT Number)

Details and patient eligibility

About

Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)

Enrollment: 66 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male subjects

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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66 participants in 3 patient groups, including a placebo group

BI 1021958

Experimental group

Description:

Single rising dose (SRD) part

Treatment:

Drug: BI 1021958

Drug: BI 1021958

BI 1021958 (Food effect)

Experimental group

Description:

Food effect part (FE)

Treatment:

Drug: BI 1021958

Drug: BI 1021958

Placebo to BI 1021958

Placebo Comparator group

Description:

Matching placebo as drinking solution and tablets

Treatment:

Drug: Placebo to BI 1021958