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About
The purpose of this study is to determine whether SB-649868 is safe, tolerable after repeated administrations in adult and elderly healthy volunteers. Pharmacokinetics and effects on cardiac function of repeated doses are studied
Full description
The present clinical study will assess safety, tolerability and pharmacokinetics of SB-649868 20mg administered for 28 consecutive days in adult (18 to 65 yrs old) and elderly (>65 yrs old) men and women. The study will also assess cardiac function using echocardiography.
Enrollment
Sex
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Volunteers
Inclusion criteria
Healthy male or female subject 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. However,
Age > or equal to 18 years (applied only to Cohort 1 and 2); age >65 years (applied only to Cohort 3 and 4);
Body weight ≥50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive. Slight deviations from these values will be discussed and approved by the Investigator and the GSK Medical Monitor to allow subject inclusion into the study
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 3 days post last dose (equivalent to 5 terminal half-lives post-last dose).
A female subject is eligible to participate if she is of:
Having given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Average QTcB or QTcF < 450 msec; PQ 120-220ms; QRS <120ms; no significant rhythm disorders in SCR 24h Holter-ECG
Exclusion criteria
History or presence of significant psychiatric, neurological, respiratory, gastrointestinal, hepatic, pancreatic or renal diseases or of any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
History of cardiovascular diseases and/or evidence of repolarization defects
History of regular alcohol consumption within 6 months of the study defined as:
• an average weekly intake of greater than 21 units (14 units for female) or an average daily intake of greater than 3 units (2 units for female). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.
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.
Vulnerable subjects , or subject is mentally or legally incapacitated, or language barrier precluding adequate understanding of cooperation.
Any history of suicidal behaviour or any suicidal ideation of type 4 or 5 in the last month on the C-SSRS administered at screening
Pregnant females as determined by positive Serum beta-hCG test at screening or prior to dosing.
Lactating females.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
A positive test for HIV antibody.
cTpn I values above of 99th percentile of the laboratory reference interval
A positive pre-study drug/alcohol screen.
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
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.
Consumption of broccoli, radish sprouts, cauliflower, cabbage, orange juice, grapefruit juice or grapefruit within 7 days prior to the first dose of study medication until collection of the final pharmacokinetic blood sample.
The subject has participated in a clinical trial and has received an IP 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 IP (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
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.
The subject is unable or unwilling to abstain from strenuous physical activity in the 48 h before screening and up to the follow up visit.
Subject is the investigator or his/her deputies, research assistant, pharmacist, study coordinator, other staff or relative thereof involved in the conduct of the study.
Primary purpose
Allocation
Interventional model
Masking
72 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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