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

NCT00500461 | Completed Phase 1

• 1 other identifier: AC2106213
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Muscarinic Receptor Antagonist,; intravenous infusion,; pharmacokinetics; healthy subjects,; safety,; tolerability,; Anticholinergic,; oral dosing,

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability of GSK233705: lead II monitoring out to 8 hours post dose,

  out to 8 hours post dose

• measurement of heart rate, blood pressure and ECG, Holter monitoring and laboratory data out to 24 hours and

  out to 24 hours

• review of adverse events ongoing through out study.

  through out study.

Secondary Outcomes (1)

• Plasma and urine concentrations of GSK233705 and derived pharmacokinetic parameters, out to 48 hours post dose.

  out to 48 hours post dose.

Study Arms (1)

Subjects receiving GSK233705

EXPERIMENTAL

Each subject will receive one or more ascending doses given as a constant rate IV infusion over 30 minutes and a single oral dose of 250 microgram GSK233705 solution. IV doses will include 30, 70, 110 microgram of GSK233705 at specified time points.

Drug: GSK233705

Interventions

GSK233705 DRUG

GSK233705 will be available as IV infusion and oral solution containing Cellobiose octaacetate.

Subjects receiving GSK233705

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7NS, United Kingdom

Location

Related Publications (1)

• This study has not been published in the scientific literature.

  BACKGROUND

Related Links

• Results for study AC2106213 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: June 4, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 25, 2007
• Last Updated: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)