Succinate Salt Version of GSK961081 for Healthy Volunteers - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00550225

Purpose

Salt Bridging study for GSK961081

Condition	Intervention	Phase
Healthy Subjects	Drug: GSK961081	Phase I

MedlinePlus related topics: Dietary Sodium

Drug Information available for: Succinic acid Sodium chloride

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Randomised, Double-Blind, Dose Escalating Study in Healthy Volunteers to Assess the Safety, Tolerability, Extra Pulmonary Pharmacodynamics and Pharmacokinetics of Single Doses of GSK961081 (Succinate Salt)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Secondary Outcome Measures:

Plasma concentrations of GSK961081 at intervals [ Time Frame: during the 10 week study ]
PK parameters at intervals [ Time Frame: during the 10week study ]

Eligibility

Criteria

Inclusion Criteria:

Healthy adult males or female aged between 18 and 50 years.
Body mass index within the range 19-29.9 kilograms/metre2
Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7
Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years.

Exclusion criteria:

Who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
History of respiratory disease
Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec
Supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort.
Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 3 months
Infected with the Hepatitis B, Hepatitis C, or HIV virus
Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550225

Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD MDsc FFPM

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	MAB108115
Study First Received:	October 26, 2007
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00550225
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:

anti-muscarinic,
b-agonist,
succinate

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 15, 2009