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This study will be the first repeat dose administration of GSK1322322 to investigate safety, tolerability, and pharmacokinetics in healthy subjects as well as elderly volunteer subjects. The study will also include a P450 probe drug (midazolam) to evaluate the effect of GSK1322322 to inhibit or induce CYP3A4 substrates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | A single AM dose of GSK1322322/placebo on Day 1, no dosing on Day 2, and BID dosing on Days 3-12. |
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| Cohort B | Experimental | Subjects will receive a single AM dose of GSK1322322/placebo on Day 1, no dosing on Day 2, and BID dosing on Days 3-12. |
|
| Cohort C | Experimental | Subjects in the probe cohort will receive a single AM dose of GSK1322322/placebo on Day 1, no dosing on Day 2, and BID dosing on Days 3-12. All subjects will receive a single dose of midazolam alone on Day -1, and co-administered with the morning dose of GSK1322322/placebo on Day 1 and Day 12. |
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| Cohort D | Experimental | Subjects will receive a single AM dose of GSK1322322/placebo on Day 1, no dosing on Day 2, and BID dosing on Days 3-12. |
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| Cohort E | Experimental | Subjects will receive a single AM dose of GSK1322322/placebo on Day 1, no dosing on Day 2, and BID dosing on Days 3-12. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1322322/placebo | Drug | GSK1322322/placebo escalating doses from 500mg to 1500mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| GSK1322322 safety parameters, adverse events , absolute values and changes over time of clinical lab testing, vital signs, electrocardiogram | 6 weeks | |
| GSK1322322 pharmacokinetic parameters following single dose administration on Day 1 and following repeat administration where applicable on Day 7 and Day 12. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| PK for midazolam with and without GSK1322322 | 15 days | |
| Blood PK for GSK1322322 | 15 days | |
| Urine PK for GSK1322322 |
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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 | Randwick | New South Wales | 2031 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23557930 | Background | Naderer OJ, Dumont E, Zhu J, Kurtinecz M, Jones LS. Safety, tolerability and pharmacokinetics of repeat dosing of the antibiotic GSK1322322, a peptide deformylase inhibitor: a randomized placebo-controlled study. J Antimicrob Chemother. 2013 Aug;68(8):1901-9. doi: 10.1093/jac/dkt097. Epub 2013 Apr 3. |
| Label | URL |
|---|---|
| Results for study 112668 can be found on the GSK Clinical Study Register. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 112668 | Annotated Case Report Form | 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 |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C583947 | GSK1322322 |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| GSK1322322/placebo and midazolam | Drug | GSK1322322/placebo and 5mg midazolam |
|
| 15 days |
| GSK1322322 Age Effect on PK Blood and Urine | 15 days |
| 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 |
| 112668 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112668 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112668 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112668 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112668 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 112668 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D006571 | Heterocyclic Compounds |