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This study is a Phase I open label drug interaction study to evaluate the effect of omeprazole and ritonavir on GSK2336805.
This study is a Phase I open label drug interaction study with two objectives. The first objective of this study (Cohort 1) is to determine if the pharmacokinetics of a single dose of GSK2336805 are affected by co-administration with repeat doses of omeprazole, a proton-pump inhibitor that is commonly used by chronic hepatitis C patients .
The second objective of this study (Cohort 2) is to determine if the pharmacokinetics of a single dose of GSK2336805 are affected by co-administration with repeat doses of ritonavir, a HIV protease inhibitor drug that is a potent inhibitor of CYP 3A4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | GSK2336805 60mg x 1 dose (fasted) [Reference Treatment] |
|
| Treatment B | Experimental | Omeprazole 40 mg q24h x 4 days (fed) |
|
| Treatment C | Experimental | GSK2336805 60 mg x 1 dose and Omeprazole 40 mg on Day 1 (fasted) [Test Treatment] |
|
| Treatment D | Experimental | GSK2336805 30mg x 1 dose (fasted) [Reference Treatment] |
|
| Treatment E | Experimental | Ritonavir 100mg q12h x 4 days (fed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose) | Drug | GSK2336805 and Omeprazole |
|
| Measure | Description | Time Frame |
|---|---|---|
| area under the plasma concentration time curve from time zero to the last quantifiable time points | PK parameter | 48 hours |
| under the plasma concentration time curve from time zero to infinity | PK parameter | 48 hours |
| area under the plasma concentration time curve from time zero to 24 hours | PK parameter | 24 hours |
| maximum observed concentration | PK parameter | 48 hours |
| time to maximum observed concentration | PK parameter | 48 hours |
| concentration at 24 hours post-dose | PK parameter | 24 hours |
| last measureable concentration | PK parameter | 48 hours |
| time of last measurable concentration | PK parameter | 48 hours |
| absorption lag time | PK parameter |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Adverse Events | Safety parameter | 24 hours |
| Number of subjects needing concurrent medications | Safety parameter |
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Inclusion Criteria:
Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, oophorectomy, or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea
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 | Buffalo | New York | 14202 | United States |
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| Label | URL |
|---|---|
| Results for study 115711 can be found on the GSK Clinical Study Register. | View source |
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| Treatment F | Experimental | GSK2336805 30 mg x 1 dose (fasted) and ritonavir 100mg q12h on Day 1 (fasted) [Test Treatment] |
|
| Treatment G | Experimental | Ritonavir 100mg q12h x 1 day |
|
| Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose) | Drug | GSK2336805 and Ritonavir |
|
| 48 hours |
| the elimination half-life | PK parameter | 48 hours |
| apparent oral clearance | PK parameter | 48 hours |
| apparent volume of distribution | PK parameter | 48 hours |
| 24 hours |
| Number of subjects with clinical laboratory tests of clinical significance | Safety parameter | 24 hours |
| Number of subjects with electrocardiograms with clinically significant values | Safety parameter | 24 hours |
| Number of subjects with vital sign measures of clinical significance | Safety parameter | 24 hours |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000595241 | GSK2336805 |
| D009853 | Omeprazole |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013844 | Thiazoles |
| D001393 | Azoles |
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