GSK573719 IV Enabling Study

NCT01110018 | Completed Phase 1

• 1 other identifier: 112008
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A single-centre, open-label, sequential, cross-over study to examine the safety, tolerability and pharmacokinetics of 3 ascending single intravenous doses, a single 1000μg oral dose and a single 1000μg inhaled dose of GSK573719 in healthy male volunteers.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Tolerability; COPD; Safety; Muscarinic receptor (mAChR) antagonist; GSK573719; Healthy subjects; Pharmacokinetics; IV study

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of GSK573719

  Study duration (5 weeks)

Secondary Outcomes (3)

• IV dose plasma PK parameters: AUC(0-∞) (if calculable), AUC(0-t), and Cmax, tlast, CL, Vss, MRT, λz and t½

  Pre-dose to 24h post-dose (48h post-dose in IV dose 3)

• Oral and Inhaled dose plasma PK parameters: AUC(0-∞) (if calculable), AUC(0-t) and Cmax, tmax, tlast, F, λz and t½, if calculable.

  Pre-dose to 24h post-dose

• Urine PK parameters for all routes of administration: CLr, t½, Ae(0-2), Ae(0-4) , Ae(0-8) , Ae(0-12) , Ae(0-24) , Ae(0-36), Ae(0-48), fe, F , AUER(0-18), AUER(0-36) if available, AUER(0-∞).

  0-48h post-dose

Study Arms (5)

Period 1

ACTIVE COMPARATOR

20μg intravenous infusion administered over 30 minutes

Drug: GSK573719 (SOLUTION)

Period 2

ACTIVE COMPARATOR

1000μg Oral dose

Drug: GSK573719 (SOLUTION)

Period 3

ACTIVE COMPARATOR

50μg Intravenous infusion administered over 30 minutes

Drug: GSK573719 (SOLUTION)

Period 4

ACTIVE COMPARATOR

1000μg Inhaled dose

Drug: GSK573719 (INHALATION POWDER)

Period 5

ACTIVE COMPARATOR

100μg Intravenous infusion administered over 30 minutes

Drug: GSK573719 (SOLUTION)

Interventions

GSK573719 (SOLUTION) DRUG

20μg /mL solution for IV and Oral dosing

Period 1; Period 2; Period 3; Period 5

GSK573719 (INHALATION POWDER) DRUG

500μg inhalation powder delivered via Novel Dry Powder Inhaler. GSK573719 1000μg per dose (2x 500μg strips in device).

Period 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
• Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until follow up.
• Body Mass Index within the range 18-30 kg/m2 (inclusive).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Average QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.
• Non-smokers (never smoked or not smoking for \>6 months with \<10 pack years history (Pack Years = (cigarettes per day smoked/20) x number of years smoked)

You may not qualify if:

• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
• A positive pre-study drug/alcohol screen.
• A positive test for HIV antibody.
• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of \>21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (\~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• Subject is mentally or legally incapacitated.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, NW10 7EW, United Kingdom

Location

Related Links

• Results for study 112008 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

Interventions

GSK573719; Solutions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 23, 2010
• Study Start: April 28, 2010
• Primary Completion: June 9, 2010
• Study Completion: June 9, 2010
• Last Updated: June 27, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)