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A Blinded, Dose Ascending Study to Assess the Pharmacokinetics, Safety and Tollerability of Repeat Inhaled Doses of Nebulised GW870086X in Healthy Adult Male Volunteers.

NCT01160003 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-06-14

No results posted yet for this study

Summary

This study is a randomised, double-blind, placebo-controlled, dose ascending, 3-way crossover study in healthy adult male volunteers. The primary objective of the study is to assess the pharmacokinetics of 14 days dosing of GW870086X administered via nebules formulation. The secondary objective is to assess the safety and tolerability of repeat doses of nebulised GW870086X.

Conditions

Interventions

DRUG

GW870086X

5mg and 8.75mg GW870086X once daily for 14 days in separate traetment periods.

DRUG

Placebo

placebo will be randomly inserted into one of the treatment periods following the treatment sequences outlined in the protocol.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-07-29
Primary Completion
2010-11-05
Completion
2010-11-05

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT01160003 on ClinicalTrials.gov