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CompletedNCT00500461Updated Aug 7, 2017

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

A Phase 1 interventional study of GSK233705 in Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to male participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-07.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Non-randomized
Ages
25 Years to 55 Years
Sex
Male
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Study 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.

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Conditions studied

  • Pulmonary Disease, Chronic Obstructive

Keywords

  • Muscarinic Receptor Antagonist,
  • intravenous infusion,
  • pharmacokinetics
  • healthy subjects,
  • safety,
  • tolerability,
  • Anticholinergic,
  • oral dosing,
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In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's enrollment of 9 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    Subjects receiving GSK233705

    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

  • DrugGSK233705

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

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What researchers measure

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.

07

Study locations

1 site
  • GSK Investigational Site
    London, NW10 7NS, United Kingdom
08

References and documents

Publications

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

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00500461
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 12, 2007
Start date
Jun 4, 2007
Primary completion
Jul 1, 2007
Completion
Jul 25, 2007
Last update
Aug 7, 2017

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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