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Study to Investigate the Effect of GSK1014802 on Ambulatory Blood Pressure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00955396
First Posted: August 10, 2009
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
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.

Condition Intervention Phase
Healthy Volunteer Drug: GSK1014802 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Randomized, Double-blind, Placebo-controlled Cross-over Study to Investigate the Effect of GSK1014802 on Ambulatory Blood Pressure

Further study details as provided by Biogen:

Primary Outcome Measures:
  • Change in 24 h average SBP and DBP from Baseline to Day 36. [ Time Frame: 36 days ]

Secondary Outcome Measures:
  • Change in 24 h average SBP and DBP from Baseline to Day 15. Change in average SBP and DBP within a dosing interval (12 h) from Baseline to Days 14 and 35. [ Time Frame: 35 days ]
  • Change in 24 h average SBP and DBP from Baseline to Days 15 and 36 in subjects with baseline SBP 120-139 mmHg and also DBP 80-89 mmHg. [ Time Frame: 36 days ]
  • Change in day-time outpatient (6:00 AM to 10:00 PM) SBP and DBP from Baseline to Days 15 and 36. [ Time Frame: 36 days ]
  • Change in night-time outpatient (10:00 PM to 6:00 AM) SBP and DBP from Baseline to Days 15 and 36. [ Time Frame: 36 days ]
  • Change in 24 h average ambulatory heart rate from Baseline to Days 15 and 36. [ Time Frame: 36 days ]
  • Proportion of patients whose 24 h systolic and diastolic BP increased by < 5, 5-9, 1014, 15-19, and > 20 mm Hg compared to baseline. [ Time Frame: 36 days ]
  • PK parameters of GSK1014802 following a single oral dose of GSK1014802 to healthy female subjects: Cmax, tmax, AUC (0-t) and, if possible, AUC(0-∞), λz and terminal phase half-life to healthy female subjects. [ Time Frame: 1 day ]
  • PK parameters of GSK1014802 following repeated oral doses of GSK1014802 given twice daily to healthy male and female subjects: Cmax, tmax, AUC(0-12). [ Time Frame: 36 days ]
  • PK/PD analyses to examine the correlation between ambulatory blood pressure and plasma levels and/or metrics of the systemic exposure (Cmax, AUC) of GSK1014802. [ Time Frame: 36 days ]

Enrollment: 60
Actual Study Start Date: July 31, 2009
Study Completion Date: December 31, 2009
Primary Completion Date: December 31, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Period 1 Drug: GSK1014802
Tablets
Other Name: BIIB074 and CNV1014802
Drug: Placebo
Tablets
Period 2 Drug: GSK1014802
Tablets
Other Name: BIIB074 and CNV1014802
Drug: Placebo
Tablets

Detailed Description:
This study, previously posted by GlaxoSmithKline (GSK), was transitioned to Convergence Pharmaceuticals, Ltd., which spun off from GSK. Convergence Pharmaceuticals, Ltd., has now been acquired by Biogen.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955396


Locations
United States, New York
GSK Investigational Site
Buffalo, New York, United States, 14202
Sponsors and Collaborators
Biogen
Investigators
Study Director: Biogen Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00955396     History of Changes
Other Study ID Numbers: 113210
SCB113210
First Submitted: August 6, 2009
First Posted: August 10, 2009
Last Update Posted: October 16, 2017
Last Verified: October 2017

Keywords provided by Biogen:
sodium channel blocker
ambulatory blood pressure