Clinical Trial: Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomised Double Blind (Sponsor Unblinded), Single and Repeat Ascending Dose First Time in Human Study in Healthy Subjects, Cold Urticaria and Chronic Spontaneous Urtic

Brief Summary: This First Time in Human (FTIH) study, which will be performed in three parts, is designed to investigate the safety, local tolerability, pharmacokinetics and pharmacodynamics after single and repeat topical applications of up to 2 strengths of GSK2646264 and corresponding placebo within the same subject, in healthy adult subjects (Part A), subjects with cold urticaria (CU, Part B) and subjects with chronic spontaneous urticaria (CsU, Part C). The study will also measure short term effects of GSK2646264 on the number and size of weals in subjects with CsU, and in healthy subjects and subjects with CU following provocation tests.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Part A Group 1: Number of participants with adverse events (AEs) and serious AEs (SAEs) by severity and frequency [ Time Frame: up to 7 days ]
    AEs will be collected from the start of study treatment and until the follow-up contact
  • Part A Group 2: Number of participants with AEs and SAEs by severity and frequency [ Time Frame: up to 11 days ]
    AEs will be collected from the start of study treatment and until the follow-up contact
  • Part B: Number of participants with AEs and SAEs by severity and frequency [ Time Frame: up to 7 days ]
    AEs will be collected from the start of study treatment and until the follow-up contact
  • Part C: Number of participants with AEs and SAEs by severity and frequency [ Time Frame: up to 14 days ]
    AEs will be collected from the start of study treatment and until the follow-up contact
  • Part A Group 1: Twelve lead electrocardiogram (ECG) assessments [ Time Frame: up to 7 days ]
    ECG will be taken using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc interval Friderica's.
  • Part A Group 2: Twelve lead ECG assessments [ Time Frame: up to 11 days ]
    ECG will be taken using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc interval Friderica's.
  • Part B: Twelve lead ECG asse

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Part A Group 1: Composite of PK parameters of GSK2646264 measured by maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), area under the plasma concentration-time curve (AUC) and apparent terminal elimination half-life (t1/2) [ Time Frame: PK samples will be collected at pre-dose, and at 1, 2, 4, 8, 12, and 24 hours post dose from Day 1 to Day 3 ]
    • Part A Group 2: Composite of PK parameters of GSK2646264 as measured by Cmax, Tmax, AUC and t1/2 [ Time Frame: PK samples will be collected at pre-dose, and at 1, 2, 4, 8, 12, and 24 hours post dose from Day 1 to Day 7 ]
    • Part B: Composite of PK parameters of GSK2646264 as measured by Cmax, Tmax, AUC and t1/2 [ Time Frame: PK samples will be collected at pre-dose, and at 1, 2, 4, 8, 12, and 24 hours post dose on Day 1 and Day 3 ]
    • Part C: Composite of PK parameters of GSK2646264 as measured by Cmax, Tmax, AUC and t1/2 [ Time Frame: PK samples will be collected at pre-dose, 2 and 4 hours post dose on Day 1, Day 4 and Day 7 ]


    Original Secondary Outcome: Same as current

    Information By: GlaxoSmithKline

    Dates:
    Date Received: November 13, 2014
    Date Started: November 17, 2014
    Date Completion: July 31, 2017
    Last Updated: May 1, 2017
    Last Verified: May 2017