GSK2018682 FTIH in Healthy Volunteers
A Single-blind, Placebo-controlled, Two Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of GSK2018682 in Healthy Volunteers
What it found
We found no results in the registry or in papers.
This trial finished 15 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Gsk-2018682
Placebo
- Placebo
What it measured
Main measures
To investigate the safety and tolerability of single escalating oral doses of GSK2018682
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
SafetyTo investigate effects of GSK2018682 on heart rate and blood pressure
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
SafetyTo investigate the pharmacokinetics of single doses of GSK2018682
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
How the body handles the medicineEvaluate the effect of single escalating oral doses of GSK2018682 on lymphocytes (totals plus subsets)
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
Immune response
Who could take part
MS (type not specified) · 18 to 55
Show the full criteria
Inclusion criteria
* 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 significantly 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 lymphocyte counts outside the normal range should always be excluded from enrollment * BMI within the range 19 - 28 kg/m2 (inclusive).
Exclusion criteria
* 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 * Subjects with a history of, or examination suspicious for, skin cancer(s) including melanoma, basal cell or squamous cell carcinoma. * Systolic blood pressure less than 95 mmHg or greater than 140 mmHg, or diastolic blood pressure less than or equal to 50 mmHg or greater than or equal to 95 mmHg. * Symptomatic reduction in blood pressure after orthostatic challenge. * Subjects with resting heart rate less than 45 beats per minute or greater than 90 beats per minute Other criteria may apply as defined by the clinical protocol.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This protocol describes the first administration of GSK2018682 to humans. The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682. The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.
Papers
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History
Started
May 2010
Main results due
Dec 2010
Finished
Dec 2010