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GW273225 is in development for epilepsy and bipolar disorder and can affect women of child bearing potential. A clear understanding of the potential interaction between oral contraceptives and GW273225 is therefore important for clinical investigation of GW273225 in a large number of patients. This study will investigate whether there is any effect of GW273225 upon the components of combined oral contraceptive, and also whether taking oral contraceptives affects the pharmacokinetics (PK) of GW273225.
26 healthy female subjects, aged 18-45 years will take an oral contraceptive (150ug levonorgestrel and 30ug ethinylestrdiol; The study will include a screening period, two cycles on oral contraceptive with GW273225 at 25 mg once per day administered from the start of the second COC cycle for 47 days. There will be a follow-up visit 14-21 days later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence ABC | Experimental | All subjects will receive the treatment sequence ABC where A=combined oral contraceptive pill (COC), B=COC plus GW273225 and C=GW273225. COC will be administered in two cycles that is, cycle 1 (Days 1-21) and cycle 2 (Days 29-49) of the study. The cycles will be separated by a 7 day washout period. GW273225 will be administered at a dose of one 25 milligram tablet once daily on Days 29-75 of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW273225 | Drug | GW273225 will be available as 25 milligram tablets. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 0-24hrs PK of oral contraceptive components | 0-24hrs |
| Measure | Description | Time Frame |
|---|---|---|
| 0-24hrs PK of GW273225 Hormone levels with co-administration of oral contraceptive and GW273225 | 0-24hrs | |
| blood drug levels of GW273225 in the presence or absence of the Combined Oral Contraceptive (COC) | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dosing on Day 49 and Day 75 |
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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 | Cambridge | Cambridgeshire | CB3 7TR | United Kingdom |
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| Label | URL |
|---|---|
| Results for study 107110 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| COC |
| Drug |
COC will consist of Microgynon 30 which is available as ethinylestradiol 30 micrograms/levonorgestrel 150 micrograms beige color, sugar-coated tablets. |
|
| blood levels of ethinylestradiol and levonorgestrel of the COC in the presence or absence of GW273225. | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 hours post dosing on Day 21 and Day 49 |
| blood levels of FSH, LH and progesterone | Up to Day 45 |
| blood levels of Oestradiol and SBHG | Up to Day 45 |
| Electrocardiogram (ECG) recordings | Up to Day 96 |
| Adverse events | Up to Day 96 |
| Vital signs | Up to Day 96 |