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Assessment of Exposure of BI 409306 in Cerebrospinal Fluid (CSF) Relative to Plasma as Well as to Evaluation of the Effect of Different Doses of BI 409306 on the cGMP (Cyclic Guanosine Monophosphate) Levels in CSF in Healthy Male Volunteers

NCT01493570 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-03-21

Study results available
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Summary

Due to the exploratory nature of this trial, there is no primary objective in a confirmatory sense. The study aims

\- to evaluate the effect of different doses of BI 409306 on biomarker and to assess the exposure of BI 409306

Conditions

  • Healthy

Interventions

DRUG

BI 409306

Film-coated tablet

DRUG

Placebo

Film-coated tablet

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-01
Primary Completion
2012-02-01
Completion
2012-02-21

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
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 NCT01493570 on ClinicalTrials.gov