Clinical Trial: Phase 1 Study of GSK2315698 in Healthy Japanese Subjects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Single Centre, Double-blind, Randomised, Placebo-controlled, and Single Dose-ascending Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics, of Single Intravenous Do

Brief Summary:

This is the first study in which GSK2315698 will be administered in Japanese population. The primary objective of the study is to investigate safety and tolerability, pharmacokinetics, and pharmacodynamics after single intravenous infusion in healthy subjects. This will be a single center, double-blind, randomized, placebo-controlled, dose-ascending study.

Subjects in Cohort 1 will attend 3 dosing sessions, and will be randomized to one of the 3 groups. Each group will receive GSK2315698 and Placebo in a defined sequence. The dose levels of GSK2315698 are set to 10 milligrams (mg) per hour (hr), 20 mg/hr, and 40 mg/hr, to be administered over 1 hour. Dosing sessions 1 and 2, and dosing sessions 2 and 3, will be separated by a washout period of at least 8 and 10 days, respectively.

Subjects in Cohort 2 will attend a single dosing session, and will be randomized to receive either GSK2315698 20 mg/hr or Placebo, over a period of 15 hours.

A sufficient number of subjects will be randomized such that 18 subjects (9 in each cohort) complete the study. The duration of participation for any subject in this study will be approximately 59 days.


Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Number of subjects with adverse events (AE) and serious adverse events (SAE) [ Time Frame: Over a maximum period of approximately 29 days ]
  • Number of subjects with abnormalities in clinical laboratory parameters [ Time Frame: Over a maximum period of approximately 59 days ]
    Abnormalities will be assessed in laboratory parameters of hematology, clinical chemistry, and routine urinalysis.
  • Number of subjects with abnormalities in vital sign parameters [ Time Frame: Over a maximum period of approximately 59 days ]
    Abnormalities will be assessed in the vital signs of respiratory rate, pulse rate, blood pressure, and body temperature. Vital signs will be measured in a supine position after 5 minutes of rest.
  • Number of subjects with electrocardiogram (ECG) abnormalities [ Time Frame: Over a maximum period of approximately 59 days ]
    Single 12-lead ECG will be obtained using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT interval corrected for heart rate by Fridericia's formula (QTcF) intervals.
  • Plasma concentration of GSK2315698 [ Time Frame: Pre-dose and 0.25, 1, 2, 4, 6, 8, 12, 24 hours post-dose in Cohort 1; Day 1 (pre-dose and 0.25, 1, 4, 12, 15, 18, 24 hours post-dose), and Days 5, 8, 14 in Cohort 2 ]
    Whole blood samples of approximately 2 milliliters (mL) will be collected for measurement of plasma concentrations of GSK2315698.
  • Maximum observed plasma concentration (Cmax) of GSK231569

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: GlaxoSmithKline

    Dates:
    Date Received: November 1, 2016
    Date Started: November 2016
    Date Completion:
    Last Updated: January 18, 2017
    Last Verified: January 2017