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Study To Examine Safety, Tolerability And Pharmacokinetics Of Intravenous Doses And Oral Dose Of GSK233705

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00500461
First received: July 10, 2007
Last updated: October 15, 2008
Last verified: October 2008
  Purpose

GSK233705 is being developed for the treatment of chronic obstructive pulmonary disease. This will be an open-label, dose-ascending study in 7 healthy male subjects to establish well tolerated intravenous doses and an oral dose of GSK233705. The main objective of the study is to confirm an IV and oral dose for a definitive human radiolabel metabolic study.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: GSK233705
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Centre, Open-Label, Sequential Ascending Cross Over Study to Examine Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Ascending Single Doses, Nominally 10, 30, 70 and 110µg Intravenous Doses and a Single 250µg Oral Dose of GSK233705 in Healthy Volunteers.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose, [ Time Frame: out to 8 hours post dose ]
  • measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and [ Time Frame: out to 24 hours ]
  • review of adverse events ongoing through out study. [ Time Frame: through out study. ]

Secondary Outcome Measures:
  • Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters, out to 48 hours post dose. [ Time Frame: out to 48 hours post dose. ]

Enrollment: 9
Study Start Date: June 2007
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GSK233705
    Other Name: GSK233705
  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects;
  • Between the ages of 18-55 years, inclusive
  • Body mass index within the range 18.0 to 30.0 kg/m2.
  • Non-smokers
  • Adequate venous access for intermittent cannulation
  • A signed and dated written informed consent is obtained from the subject
  • The subject is capable of giving informed consent
  • Available to complete the study

Exclusion Criteria:

  • Any clinically important abnormality identified in the following: at the screening medical assessment
  • A mean QTc(B) value at screening >450msec, the QTc(B) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 90-210msec or an ECG that is not suitable for QT measurements
  • A history of elevated resting blood pressure or a mean blood pressure higher than 140/90 mmHg at screening.
  • A mean heart rate outside the range of 40-90 bpm at screening.
  • History of use of tobacco- or nicotine-containing products within 6 months of screening or a positive cotinine test at screening.
  • The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
  • The subject is currently taking regular (or course of) medication, whether prescribed or not, including herbal remedies such as St John's Wort.
  • The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications (except simple analgesics) within 48 hours prior to dosing, unless it is judged by the Investigator not to compromise their safety or influence the outcome of the study.
  • The subject has participated in a study with a new molecular entity within a period of 3 months prior to dosing.
  • The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500461

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom, NW10 7NS
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00500461     History of Changes
Other Study ID Numbers: AC2106213
Study First Received: July 10, 2007
Last Updated: October 15, 2008
Health Authority: United Kingdom: National Research Ethics Service (NRES)

Keywords provided by GlaxoSmithKline:
Muscarinic Receptor Antagonist,
Anticholinergic,
healthy subjects,
oral dosing,
intravenous infusion,
safety,
tolerability,
pharmacokinetics

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014