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OpenTrials
Completed

NCT Number: NCT00500461

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

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.

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Key information

Age range

25 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

London, NW10 7NS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK233705

Drug

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

Primary outcomes

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

    Time frame: out to 8 hours post dose

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

    Time frame: out to 24 hours

  3. review of adverse events ongoing through out study.

    Time frame: through out study.

Secondary outcomes

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

    Time frame: out to 48 hours post dose.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 12, 2007
Registry last updated
Aug 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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