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Multiple Rising Oral Doses of BI 1060469 in Healthy Subjects and Mild Asthma Patients

NCT02126865 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2015-08-14

No results posted yet for this study

Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1060469 in healthy male and female subjects after oral administration of repeated rising doses of 3 mg, 10 mg, 25 mg, 75 mg, 150 mg and 250 mg qd. of 1 day followed by 14 days and in asthmatic male and female patients after oral administration of repeated rising doses of 25 mg and 150 mg qd of 1 day followed by 28 days.

Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality, dose linearity after single and multiple dose segments, pharmacodynamics (PD) of BI 1060469 and to describe the PK/PD relationship.

Conditions

Interventions

DRUG

Placebo to BI 1060469

tablet

DRUG

BI 1060469 Healthy

tablet

DRUG

Placebo to BI 1060469 asthmatics

tablet

DRUG

BI 1060469 asthmatics

tablet

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02126865 on ClinicalTrials.gov