Intravenous Microdose Pharmacokinetic (PK) Study With [14C]-GSK2239633

NCT01086462 | Completed Phase 1

• 1 other identifier: 114041
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a first administration to man microdose study to describe the pharmacokinetics of GSK2239633.

Conditions

Asthma

Keywords

GSK2239633; RADIOLABEL; PHARMACOKINETICS; INTRAVENOUS; MICRODOSE

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (AUC0-inf, Cmax, AUC0-t, t1/2, clearance, volume of distribution) of [14C]-GSK2239633 and total drug-related material

  48 hours

Study Arms (1)

GSK2239633

EXPERIMENTAL

Single dose infusion of study drug over 15 minutes

Drug: GSK2239633

Interventions

GSK2239633 DRUG

100 ug GSK2239633 containing approximately 10kBq \[14C\]-GSK2239633

GSK2239633

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects are defined as individuals who in the opinion of the Investigator are free from clinically significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, endocrine, neurological and psychiatric disease or malignancy as determined by medical history, physical examination, laboratory studies, and other tests (including ECG). Subjects with values outside the normal range which are deemed to be clinically relevant should always be excluded from enrollment.
• Male between 18 and 50 years of age inclusive, at the time of signing the informed consent.
• Subject must agree to use one of the contraception methods listed in Section 8.1. of the protocol. This criterion must be followed from the time of screening until 90 days after the follow up
• Body weight \>or= 50 kg and BMI within range 18.5-29.9 kg/m2 (inclusive).
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
• Single QTcF \<450 msec; or QTcF \<480 msec in subjects with Bundle Branch Block
• Lifelong non-smokers or ex-smokers of greater than 6 months and \<5 pack year history. Pack years = (cigarettes per day smoked/20) x number of years smoked.
• AST, ALT, alkaline phosphatase and bilirubin \<or=1.5 ULN (isolated bilirubin \>1.5 x ULN acceptable if bilirubin is fractionated and direct bilirubin \<35%)

You may not qualify if:

• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody within 3 months of screening
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities
• A positive pre-study drug/alcohol screen
• A positive test for HIV antibody
• History of regular alcohol consumption within 6 months of study defined as an average weekly intake of \>12 units/week for males. One unit is equivalent to 8g of alcohol; a half-pint (\~250ml) of beer, 1 glass (100ml) of wine or 1 (35 ml) measure of spirits.
• Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (including snuff, nicotine-containing gum) within 6 months prior to screening
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to first dosing: 60 days, 5 half-lives or twice the duration of the biological effect of investigational product (whichever is longer)
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day
• Participation in a clinical trial involving administration of 14C-labelled compounds within last 12 months
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days or 5 half-lives prior to the first dose of study medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with 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 procedures outlined in the protocol
• Subject is mentally or legally incapacitated
• A calculated creatinine clearance (Cockroft and Gault formula) of \<90 mL/min

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Zuidlaren, 9471 GP, Netherlands

Location

Related Publications (1)

• Cahn A, Hodgson S, Wilson R, Robertson J, Watson J, Beerahee M, Hughes SC, Young G, Graves R, Hall D, van Marle S, Solari R. Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2239633, a CC-chemokine receptor 4 antagonist, in healthy male subjects: results from an open-label and from a randomised study. BMC Pharmacol Toxicol. 2013 Feb 28;14:14. doi: 10.1186/2050-6511-14-14.

  PMID: 23448278 BACKGROUND

Related Links

• Results for study 114041 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

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: March 15, 2010
• Study Start: January 21, 2010
• Primary Completion: February 22, 2010
• Study Completion: February 22, 2010
• Last Updated: July 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)