Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02953808 | Phase 1 Study of GSK2315698 in Healthy Japanese Subjects | PHASE1 | COMPLETED | 18 | — | — | Nov 1, 2016 | Dec 1, 2016 | Jan 19, 2017 | 1 | Japan |
| NCT01406314 | SAP Depleter Dose Assessment Study in Patients | PHASE1 | COMPLETED | 17 | — | — | Oct 13, 2011 | Nov 14, 2012 | Jun 9, 2017 | 1 | United Kingdom |
| NCT01323985 | SAP Depleter Dose Escalation Study in Healthy Volunteers | PHASE1 | COMPLETED | 21 | — | — | Jan 6, 2011 | Jun 30, 2011 | Jul 21, 2017 | 1 | United Kingdom |
Abnormalities will be assessed in laboratory parameters of hematology, clinical chemistry, and routine urinalysis.
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.
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.
Whole blood samples of approximately 2 milliliters (mL) will be collected for measurement of plasma concentrations of GSK2315698.
Cmax will be calculated if data permit.
AUC0-24 will be calculated if data permit.
Tmax will be calculated if data permit.
C15hr will be calculated if data permit.
Venous blood samples of approximately 2 mL will be collected for measurement of SAP.
Cmin will be calculated if data permit.
Tmin will be calculated if data permit.
C15hr will be calculated if data permit.
comparison of predicted vs observed
changes in plasma concentrations of GSK2315698 over time
| Arm | Type | Description |
|---|---|---|
| Cohort 1 Group A | EXPERIMENTAL | 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. |
| Cohort 1 Group B | EXPERIMENTAL | 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. |
| Cohort 1 Group C | EXPERIMENTAL | 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. |
| Cohort 2 Group D | EXPERIMENTAL | In a single dosing session, subjects will receive GSK2315698 20 mg/hr as intravenous infusion over 15 hours. |
| Cohort 2 Group E | PLACEBO_COMPARATOR | In a single dosing session, subjects will receive Placebo as an intravenous infusion over 15 hours. |
| Intervention | EXPERIMENTAL | Intravenous infusion for approximately 48 hours followed by subcutaneous injection |
| GSK2315698 | EXPERIMENTAL | Intravenous infusion single dose |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 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). |
| GSK2315698 | DRUG | 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. |
Inclusion Criteria: * Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. A subject with...