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Single Dose Escalation Study FTIM in Order to Assess Safety and Tolerability of GSK610677

NCT00694902 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-08-10

No results posted yet for this study

Summary

This study is the first administration of GSK610677 to man. The main aim of this clinical study is to investigate the safety and tolerability of different doses of the investigational medicinal product GSK610677. 2 cohorts of 8 subjects (Cohorts I and II) will be enrolled into this study. Individual subjects in each cohort will have up to 3 treatment periods. In each treatment period, subjects will receive a single inhaled dose of GSK610677 or placebo. Predicted doses are: 10, 30, 50 100 250 and 500ug.For individual subjects in each cohort, there will be a minimum wash out period of at least 10 days. In this period safety and tolerability data will be collected prior to dose to the next level.After safety review meetings between the site and the sponsor following the administration of the 500 ug dose, it was decided to add an extra cohort (Cohort III) of 8 subjects and administer 1000µg. Each subject in Cohort III will undergo a screening visit, one treatment period, and a follow up visit.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

GSK610677

GSK610677 Multi-Dose Powder Inhaler will be available in the strength of 10, 50, 100 and 25 microgram with dose levels of 10, 30, 50, 100, 250, 500 and 1000 microgram. Subjects will receive GSK610677 as single inhale dose.

DRUG

Placebo

Matching Placebo for GSK610677 will be available as Multi-Dose Powder Inhaler. Subjects will receive Placebo as single inhale dose.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2008-05-26
Primary Completion
2008-09-23
Completion
2008-09-23

Countries

  • Germany

Study Locations

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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 NCT00694902 on ClinicalTrials.gov