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This protocol describes the first administration of GSK2018682 to humans. The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682. The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.
This protocol describes the first administration of GSK2018682 to humans. The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682. The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Part A will be used to confirm the prediction of GSK2018682 PK, assess its effects on lymphocytes, and monitor its safety profile in a single cohort (Cohort 1). Cohort 1 will consist of 4 subjects and explore 4 doses of GSK2018682 in 4 study sessions. In each session, three subjects will receive GSK2018682 and one subject will receive placebo. Thus, when the cohort completes, each subject will receive placebo and 3 doses of GSK2018682. |
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| Part B | Experimental | Part B will explore doses to refine the dose-response curve of GSK2018682 on lymphocyte suppression, as allowed by stopping criteria, in 1 or 2 cohorts of up to 15 subjects (Cohort 2 and Cohort 3). In Part B, up to six single ascending doses of GSK2018682 and one dose of placebo will be investigated in up to 8 sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2018682 | Drug | GSK2018682 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the safety and tolerability of single escalating oral doses of GSK2018682 | Adverse event and safety lab monitoring | Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks |
| To investigate effects of GSK2018682 on heart rate and blood pressure | 12 lead ECG and telemetry monitoring plus vital signs (systolic and diastolic blood blood pressures), heart rate, respiratory rate and temperature | Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks |
| To investigate the pharmacokinetics of single doses of GSK2018682 | Peak blood concentration, time of peak blood concentration, oral clearance, half life and AUC | Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks |
| Evaluate the effect of single escalating oral doses of GSK2018682 on lymphocytes (totals plus subsets) | Reduction from baseline in lymphocyte counts obtained at different time points after dosing and at different dose levels | Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other criteria may apply as defined by the clinical protocol.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Randwick | New South Wales | 2031 | Australia | ||
| GSK Investigational Site |
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| 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 |
| Results for study 114070 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114070 | Individual Participant Data Set | 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 |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C000625977 | GSK2018682 |
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| Drug |
Matched Placebo |
|
| Adelaide |
| South Australia |
| 5000 |
| Australia |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114070 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114070 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114070 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114070 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114070 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114070 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |