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This is a first time in human (FTIH) study of single escalating doses of investigational study drug to investigate safety, tolerability, and pharmacokinetics in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 100mg |
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| Cohort 2 | Experimental | 200mg |
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| Cohort 3 | Experimental | 400mg |
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| Cohort 4 | Experimental | 800mg |
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| Cohort 5 | Experimental | 1500mg |
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| Cohort 6 | Experimental | 2000mg |
|
| Cohort 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 100 mg GSK investigational drug | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters, adverse events, absolute values and changes over time of hematology, clinical chemistry, urinalysis, vital signs, electrocardiogram intervals, and ECG rhythm. | Eighteen days | |
| Pharmacokinetic parameters following single dose administration: area under the plasma concentration curve AUC 0 to inf, AUC 0 to t, AUC 0 to 24, maximum observed concentration , time to maximum observed concentration , terminal half life . | Two days, Three days (3000mg and 4000mg only) |
| Measure | Description | Time Frame |
|---|---|---|
| AUC 0 to inf and Cmax following single dose administration for the assessment of dose proportionality | Two days, Three days (3000mg and 4000mg only) | |
| Amount excreted of unchanged study drug and renal clearance | Two days, Three days (3000mg and 4000mg only) |
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Inclusion Criteria:
Exclusion Criteria:
an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). A standard unit is defined as 10g ethanol which is equivalent to 100mL wine, 250mL full strength beer, 470mL light beer, 30mL spirits
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23403431 | Background | Naderer OJ, Dumont E, Zhu J, Kurtinecz M, Jones LS. Single-dose safety, tolerability, and pharmacokinetics of the antibiotic GSK1322322, a novel peptide deformylase inhibitor. Antimicrob Agents Chemother. 2013 May;57(5):2005-9. doi: 10.1128/AAC.01779-12. Epub 2013 Feb 12. |
| Label | URL |
|---|---|
| Results for study 111341 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 111341 | Statistical Analysis Plan | 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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800mg with food |
|
| Cohort 8 | Experimental | 3000mg |
|
| Cohort 9 | Experimental | 4000mg |
|
| 200 mg GSK investigational drug | Drug |
|
| 400 mg GSK investigational drug | Drug |
|
| 800 mg GSK investigational drug | Drug |
|
| 2000 mg GSK investigational drug | Drug |
|
| 1500 mg GSK investigational drug | Drug |
|
| 800mg fed GSK investigational drug | Drug |
|
| 3000mg GSK investigational drug | Drug |
|
| 4000mg GSK investigational drug | Drug |
|
| AUC 0 to inf, AUC 0 to t, AUC 0 to 24, Cmax, tmax and tlag if deemed appropriate with and without high fat calorie meal | Two days, Three days (3000mg and 4000mg only) |
| 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 |
For additional information about this study please refer to the GSK Clinical Study Register |
| 111341 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111341 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111341 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111341 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111341 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 111341 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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