Study to Investigate the Effect of GSK1014802 on Ambulatory Blood Pressure

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

In this study the investigators will determine whether there is any effect of GSK1014802 on ambulatory blood pressure. This will be a randomized, double-blind, placebo-controlled, repeat dose, 2 period cross-over study conducted in healthy male and female subjects. Approximately 60 subjects will be randomised to receive GSK1014802 400 mg bid and placebo for 36 days with at least 1 week between treatment sessions. A follow-up will occur 7-14 days after the last dose.

Key facts

Study ID

NCT00955396

Run by

Biogen

People needed

60

Starts

2009-07-31

Expected to finish

2009-12-31

Last updated by the study team

2017-10-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female between 18 and 65 years of age inclusive.
• Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests, liver function and cardiac monitoring.
• A female subject is eligible to participate if she is of:
• Non-childbearing potential Child-bearing potential and agrees to use a contraception method.
• Male subjects must agree to use a contraception methods
• Body weight ≥ 50 kg and BMI within the range 19 - 40.0 kg/m2 (inclusive).
• Arm circumference ≥ 24 and ≤ 42 cm at mid level.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

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 screen.
• Alcohol levels above the legal limit for driving at screening and the detection of any alcohol within 24 h prior to the start of dosing in Treatment Periods 1 and 2.
• A positive test for HIV antibody.
• History of regular excessive alcohol consumption within 6 months of the study
• 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: 30 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.
• Use of prescription or non-prescription drugs, including any antihypertensive agent including diuretics, vitamins, herbal and dietary supplements
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy
• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 90 day period.
• Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
• Lactating females.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• Subject is mentally or legally incapacitated.
• Subjects who work at night or whose work schedule includes rotating night time (10:00 PM to 6:00 AM) work.
• Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
• Average daily caffeine intake equivalent to > 4 cups of coffee or > 6 cups of tea.
• Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
• Consumption of aged cheeses and meats, soy sauce and other tyramine rich sources within 1 day prior to the baseline assessments.
• Current or past history of symptomatic orthostatic hypotension or history of unexplained vasovagal episode(s).
• History of known or suspected seizures, including infantile febrile, unexplained significant and recent loss of consciousness or history of significant head trauma with loss of consciousness or a family history (first degree relative) of epilepsy or seizures (fits).
• Any history of suicidal behaviour or suicidal ideation of type 4 or 5 on the C-SSRS within 3 months of the screening visit.
• History or currently diagnosed sleep apnea.

Where it is running

• GSK Investigational Site — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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