A Phase 1 interventional study of Placebo and GSK2315698 in Amyloidosis, sponsored by GlaxoSmithKline. Completed at 1 site in Japan. Open to male participants aged 20 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-19.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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.
491 studies on the registry are indexed under Amyloidosis; 135 are open to participants now.
This study's enrollment of 18 is below the median of 40 across 304 interventional studies indexed under Amyloidosis.
Browse Amyloidosis studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
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Exclusion Criteria:
In dosing sessions 1, 2, and 3, subjects will receive GSK2315698 10 mg/hr, GSK2315698 20 mg/hr, and Placebo, respectively, as intravenous infusion over 1 hour.
Drug: Placebo · Drug: GSK2315698
In dosing sessions 1, 2, and 3, subjects will receive GSK2315698 10 mg/hr, Placebo, and GSK2315698 40 mg/hr, respectively, as intravenous infusion over 1 hour.
Drug: Placebo · Drug: GSK2315698
In dosing sessions 1, 2, and 3, subjects will receive Placebo, GSK2315698 20 mg/hr, and GSK2315698 40 mg/hr, respectively, as intravenous infusion over 1 hour.
Drug: Placebo · Drug: GSK2315698
In a single dosing session, subjects will receive GSK2315698 20 mg/hr as intravenous infusion over 15 hours.
Drug: GSK2315698
In a single dosing session, subjects will receive Placebo as an intravenous infusion over 15 hours.
Drug: Placebo
0.9% weight by volume (w/v) saline solution for intravenous infusion over 1 hour (in Cohort 1) or over 15 hours (in Cohort 2).
200 mg/mL stock solution for intravenous infusion over 1 hour (in Cohort 1) or over 15 hours (in Cohort 2). The stock solution will be diluted to obtain dosage levels of 10 mg/hr, 20 mg/hr, or 40 mg/hr.
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
Abnormalities will be assessed in laboratory parameters of hematology, clinical chemistry, and routine urinalysis.
Time frame: Over a maximum period of approximately 59 days
Number of subjects with abnormalities in vital sign parameters
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.
Time frame: Over a maximum period of approximately 59 days
Number of subjects with electrocardiogram (ECG) abnormalities
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.
Time frame: Over a maximum period of approximately 59 days
Plasma concentration of GSK2315698
Whole blood samples of approximately 2 milliliters (mL) will be collected for measurement of plasma concentrations 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
Maximum observed plasma concentration (Cmax) of GSK2315698
Cmax will be calculated if data permit.
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
Area under the concentration-time curve from pre-dose to 24 hours (AUC0-24) of GSK2315698
AUC0-24 will be calculated if data permit.
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
Time to maximum observed plasma drug concentration (Tmax) of GSK2315698
Tmax will be calculated if data permit.
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
Cohort 2: Plasma concentration of GSK2315698 at 15 hours (C15hr)
C15hr will be calculated if data permit.
Time frame: Pre-dose and 0.25, 1, 4, 12, and 15 hours post-dose in Cohort 2
Change from Baseline in blood concentration of serum amyloid P component (SAP)
Venous blood samples of approximately 2 mL will be collected for measurement of SAP.
Time frame: Day 1 (pre-dose and 0.25, 1, 2, 4, 6, 8, 12, 24 hours post-dose), Day 5, and Day 8 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
Minimum blood concentration (Cmin) of SAP
Cmin will be calculated if data permit.
Time frame: Day 1 (pre-dose and 0.25, 1, 2, 4, 6, 8, 12, 24 hours post-dose), Day 5, and Day 8 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
Time to minimum observed concentration (Tmin) of SAP
Tmin will be calculated if data permit.
Time frame: Day 1 (pre-dose and 0.25, 1, 2, 4, 6, 8, 12, 24 hours post-dose), Day 5, and Day 8 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
Cohort 2: Concentration of SAP at 15 hours (C15hr)
C15hr will be calculated if data permit.
Time frame: Pre-dose and 0.25, 1, 4, 12, and 15 hours post-dose in Cohort 2
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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