Last updated: 11/07/2018 07:08:55
Intravenous Microdose pharmacokinetic (PK) study with [14C]-GSK2239633
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Microdose Study to Describe the Intravenous Pharmacokinetics of [14C]-GSK2239633 in Healthy Male Subjects
Trial description: This study is a first administration to man microdose study to describe the pharmacokinetics of GSK2239633.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Pharmacokinetics (AUC0-inf, Cmax, AUC0-t, t1/2, clearance, volume of distribution) of [14C]-GSK2239633 and total drug-related material
Timeframe: 48 hours
Secondary outcomes:
Not applicable
Interventions:
Drug: GSK2239633
Enrollment:
6
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Cahn T, Hodgson ST, Wilson R, Robertson J, Watson JH, Beerahee M, Hughes SC, Young GC, Graves RH, Hall DA, van Marle S, Solari R. Copy of Copy of Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2239633, a CC-chemokine receptor 4 antagonist, in healthy male subjects. BMC Pharmacol Toxicol. 2013;14(1):14.
Medical condition
Asthma
Product
GSK2239633
Collaborators
GSK
Study date(s)
January 2010 to February 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 50 years
Accepts healthy volunteers
Yes
- 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.
- 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
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2010-22-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 114041 can be found on the GSK Clinical Study Register.
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