Study to Investigate the Effect of GSK1014802 on Ambulatory Blood Pressure

NCT00955396 | Completed Phase 1

• 2 other identifiers: 113210SCB113210
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteer

Keywords

sodium channel blocker; ambulatory blood pressure

Outcome Measures

Primary Outcomes (1)

• Change in 24 h average SBP and DBP from Baseline to Day 36.

  36 days

Secondary Outcomes (9)

• 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.

  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.

  36 days

• Change in day-time outpatient (6:00 AM to 10:00 PM) SBP and DBP from Baseline to Days 15 and 36.

  36 days

• Change in night-time outpatient (10:00 PM to 6:00 AM) SBP and DBP from Baseline to Days 15 and 36.

  36 days

• Change in 24 h average ambulatory heart rate from Baseline to Days 15 and 36.

  36 days

Study Arms (2)

Period 1

OTHER

Drug: GSK1014802; Drug: Placebo

Period 2

OTHER

Drug: GSK1014802; Drug: Placebo

Interventions

GSK1014802 DRUG

Tablets

Also known as: BIIB074 and CNV1014802

Period 1; Period 2

Placebo DRUG

Tablets

Period 1; Period 2

Eligibility Criteria

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

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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14202, United States

Location

MeSH Terms

Interventions

vixotrigine

Study Officials

• Biogen Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2009
• First Posted: August 10, 2009
• Study Start: July 31, 2009
• Primary Completion: December 31, 2009
• Study Completion: December 31, 2009
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

US (1)