Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 1021958 in Otherwise Healthy Controlled Asthmatic Subjects

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Asthma; Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01629849

1310.2

2012-000926-23 (EudraCT Number)

Details and patient eligibility

About

To investigate safety, tolerability, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic subjects

Enrollment: 84 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy male and female subjects ofn non child-bearing potential

Exclusion criteria

1. Any relevant deviation from healthy conditions except mild controlled asthma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

84 participants in 4 patient groups, including a placebo group

BI 1021958 qd

Experimental group

Description:

Multiple rising dose

Treatment:

Drug: BI 1021958 qd

Placebo to BI 1021958 qd

Placebo Comparator group

Description:

Matching placebo as tablets

Treatment:

Drug: Placebo to BI 1021958 qd

BI 1021958 bid

Experimental group

Description:

Multiple rising dose

Treatment:

Drug: BI 1021958 bid

Placebo to BI 1021958 bid

Placebo Comparator group

Description:

Matching palcebo as tablet

Treatment:

Drug: Placebo to BI 1021958 bid