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This study is a randomized, double-blind, ascending dose, placebo-controlled, incomplete crossover, single and multiple dose study in healthy Japanese male subjects to assess the pharmacokinetics and safety/tolerability of single and multiple intravenous administration of GR121167. Serial blood samples and pooled urine samples for the determination of GR121167 concentration will be collected and safety assessments will be performed for each treatment period.
The pharmacokinetics and dose proportionality of GR121167 after single intravenous administration of GR121167 at the dose levels of 100 mg, 300 mg and 600 mg will be assessed. In addition, in the final treatment period (600 mg), twice daily intravenous administrations for 5 days will be also conducted and the pharmacokinetics and accumulation will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm A | Experimental | In Arm A subjects will receive 100 mg of GR121167 in Period 1 and 300 mg of GR121167 in Period 2. In Period 3 subject will receive single doses of placebo on Day 1 and multiple doses of placebo from Day 3 to Day 8 |
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| Treatment Arm B | Experimental | In Arm B subjects will receive 100 mg of GR121167 in Period 1 and placebo in Period 2. In Period 3 subject will receive 600 mg of GR121167 as single dose on Day 1 and multiple doses of GR121167 from Day 3 to Day8 |
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| Treatment Arm C | Experimental | In Arm C subjects will receive placebo in Period 1, 300 mg of GR121167 in Period 2. In period 3 subject will receive 600 mg of GR121167 single dose on Day 1 and multiple doses from Day 3 to Day 8 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR121167 Solution | Drug | GR121167 solution will be administered intravenously. For 100 mg subject will receive 10 milliliter (mL) of solution, 30 mL for 300 mg and 60 mL for 600 mg |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of pharmacokinetics | Cmax, AUC0-inf, AUC0-last, AUC0-12, C12 (CÏ„), accumulation ratios (Ro, Rs) | Pre, 0.5, 0.75, 1, 1.5, 2, 4, 6 ,8 ,10 ,12 ,24 hrs after single dose and 5 days multiple dose, and at the trough during multiple doses |
| Safety parameters | vital signs, ECGs, clinical laboratory tests, and adverse events | upto 24 hrs after dose and 7 days after final dose |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of urinary pharmacokinetics | Ae, fe, CLr | 0-4, 4-8, 8-12, 12-24hrs after single dose |
| Profile of serum pharmacokinetics | AUC0-24, %AUCex, λz, tmax, t1/2, CL, Vz, Vss |
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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 | 160-0017 | Japan |
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| Label | URL |
|---|---|
| Results for study 115070 can be found on the GSK Clinical Study Register. | View source |
| 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 |
|---|---|---|---|
| 115070 | Informed Consent 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 |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| Placebo | Drug | Placebo solution will be administered intravenously. |
|
| Pre, 0.5, 0.75, 1, 1.5, 2, 4, 6 ,8 ,10 ,12 ,24 hrs after single dose and 5 days multiple dose |
For additional information about this study please refer to the GSK Clinical Study Register |
| 115070 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115070 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115070 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115070 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115070 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |