GSK2239633 FTIH Study

NCT01371812 | Completed Phase 1

• 1 other identifier: 114660
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this first time into human study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK2239633 in healthy male subjects.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of GSK2239633

  adverse events and clinically relevant changes in safety parameters - 12-lead ECG, telemetry, vital signs (systolic and diastolic blood pressure, heart rate, temperature), clinical laboratory data (haematology, clinical chemistry, urinalysis).

  0 - 48 hours post dose

Secondary Outcomes (3)

• Pharmacokinetics of GSK2239633

  0 - 48 hours post dose

• The relationship between the pharmacokinetics and pharmacodynamics of GSK2239633

  0 - 48 hours post dose

• The effect of food on the pharmacokinetics of GSK2239633

  0 - 24 hours post dose

Study Arms (2)

Cohort 1

EXPERIMENTAL

Interlocking design with Cohort 2. Single dose; treatment period over 2 days such that one subject will receive GSK2239633 and one subject will receive placebo on Day 1. The remaining subjects will be dosed on day 2 of each treatment period assuming adequate safety from Day 1. Placebo and an escalation of GSK2239633 from 150mg, to 600mg, to 1200mg and 1200mg with a FDA high fat/high calorie meal, will be administered over the 13 week long study allowing adequate washout period between doses.

Drug: GSK2239633; Drug: Placebo

Cohort 2

EXPERIMENTAL

Interlocking design with Cohort 1. Single dose; treatment period over 2 days such that one subject will receive GSK2239633 and one subject will receive placebo on Day 1. The remaining subjects will be dosed on day 2 of each treatment period assuming adequate safety from Day 1. Placebo and an escalation of GSK2239633 from 300mg, to 900mg, and 1500mg, will be administered over the 13 week long study allowing adequate washout period between doses.

Drug: GSK2239633; Drug: Placebo

Interventions

GSK2239633 DRUG

Drug will be orally administered at the doses and time points detailed in the 'arms' section.

Cohort 1; Cohort 2

Placebo DRUG

Placebo will be orally administered to 4 subjects in each treatment period of each cohort.

Cohort 1; Cohort 2

Eligibility Criteria

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

You may qualify if:

• Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
• 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. Subjects with values outside the normal range which are deemed to be clinically relevant should always be excluded from enrollment.
• Male subjects with female partners of child-bearing potential 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 3 months after last dose of study drug.
• Body weight ≥ 50 kg and BMI within the range 18.5-29.9 kg/m2 (inclusive).
• 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.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Average QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.

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 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: 60 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 or participation in more than 3 clinical studies within 10 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 prior to the first dose of study medication (excluding simple analgesics), 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.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• Urinary cotinine levels indicative of continued smoking or regular use of tobacco- or nicotine-containing products (including snuff, nicotine-containing gum).

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

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study 114660 can be found on the GSK Clinical Study Register.

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: June 13, 2011
• Study Start: March 29, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)