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This study is an open-label, randomized, 2 parallel group, single dose study in healthy Japanese males to assess the pharmacokinetics and safety/tolerability of single intravenous administration and single subcutaneous administration of GSK1550188. Serial blood samples for the determination of GSK1550188 concentration will be collected and safety assessments will be performed for each treatment group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1550188 200mg for SC | Active Comparator | Single SC dose of belimumab 200mg |
|
| GSK1550188 200mg for IV | Active Comparator | Single IV dose of belimumab 200 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1550188 IV | Drug | Single IV dose of belimumab 200 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of Vital signs | Systolic and diastolic blood pressure, pulse rate, body temperature | Day1-Day71 |
| Change from baseline of biomarkers | CD20+, immunoglobulin | Day-1 - Day71 |
| Immunogenicity | Presence of anti belimumab antibody | Day0 - Day71 (if necessary, 6-month) |
| Change from baseline of other safety parameters after single intravenous and subcutaneous administration | ECGs, clinical laboratory test, local tolerance evaluation (injection site), and adverse events | Day-1 - Day71 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite (or profile) of pharmacokinetics after single intravenous administration | Percentage of AUC(0-inifinity) obtained by extrapolation (%AUCex), Time of last quantifiable concentration (tlast), Systemic clearance of parent drug (CL), Volume of distribution after IV/SC administration (Vz), Volume of distribution after IV administration at steady state (Vss), Terminal phase rate constant (λz), Mean residence time(MRT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tokyo | 130-0004 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34741731 | Derived | Gupta SV, Fanget MC, MacLauchlin C, Clausen VA, Li J, Cloutier D, Shen L, Robbie GJ, Mogalian E. Clinical and Preclinical Single-Dose Pharmacokinetics of VIR-2218, an RNAi Therapeutic Targeting HBV Infection. Drugs R D. 2021 Dec;21(4):455-465. doi: 10.1007/s40268-021-00369-w. Epub 2021 Nov 6. | |
| 34628605 | Derived |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 116119 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| GSK1550188 SC |
| Drug |
Single SC dose of belimumab 200mg |
|
| Day1-Day71 |
| Composite (or profile) of pharmacokinetics after subcutaneous administration | Area under concentration-time curve (AUC) 0-7days, AUC 0-28 days, Percentage of AUC(0-infinity) obtained by extrapolationAUC(0-infinity) (%AUCex), tlast, Apparent clearance following subcutaneous dosing (CL/F), Volume of distribution after IV/SC administration (Vz)/F, λz, MRT | Day-1 - Day71 |
| Zhou X, Lee TI, Zhu M, Ma P. Prediction of Belimumab Pharmacokinetics in Chinese Pediatric Patients with Systemic Lupus Erythematosus. Drugs R D. 2021 Dec;21(4):407-417. doi: 10.1007/s40268-021-00363-2. Epub 2021 Oct 9. |
| Results for study 116119 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| 116119 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116119 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116119 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116119 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116119 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116119 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |