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This study aims to assess any impact of VH4524184 on the pharmacokinetic (PK) profile of an ethinyl estradiol (EE) and norethindrone acetate (NEA) containing oral contraceptive (OC) administered to healthy adult female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loestrin + VH4524184 | Experimental | Eligible participants entering a run-in period of 21 days (Days -28 through -8) will receive Loestrin (EE and NEA) to stabilize on the combined OCs containing EE and NEA to synchronize the menstrual cycles of multiple participants. Participants completing the run-in period will enter Treatment Period 1 and will be administered Loestrin once daily from Days 1 to 10. On Day 11, participants will enter Treatment Period 2 and will be administered Loestrin + VH4524184 once daily from Days 11 to 20. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VH4524184 | Drug | VH4524184 will be administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) from time zero (pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) of EE and NEA without coadministration with VH4524184 | Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis. | On Day 10 |
| AUC0-Tau, ss of EE and NEA with coadministration with VH4524184 | Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis. | On Day 20 |
| Maximum plasma concentration (Cmax) for EE and NEA without coadministration with VH4524184 | Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis. | On Day 10 |
| Cmax for EE and NEA with coadministration with VH4524184 | Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis. | On Day 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) and severity of AEs | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. | From Day -28 (Run-In-Period) up to approximately 2 months (Day 28 +/- 3 days) |
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Inclusion Criteria:
Exclusion Criteria:
Prior/Concomitant Therapy
• Any warnings and contraindications that apply based on Loestrin prescribing information.
Prior/Concurrent Clinical Study Experience
Female participants of childbearing potential (POCBP)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Antonio | Texas | 78209 | United States |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C020416 | norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination |
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| Loestrin |
| Drug |
Loestrin will be administered. |
|
| Number of participants with AEs leading to discontinuation of study intervention | Throughout the study treatment period (from Day -28 up to Day 20) |
| Change from baseline of liver panel laboratory parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ASP) (International units per liter) | Baseline (Day -28) up to Day 21 |
| Change from baseline of liver panel laboratory parameters: Total bilirubin, Direct bilirubin (Micromoles per liter [umol/L]) | Baseline (Day -28) up to Day 21 |
| Change from baseline of liver panel laboratory parameters: International normalized ratio (INR) (Ratio) | Baseline (Day -28) up to Day 21 |
| Number of participants with maximum toxicity grade increase from baseline of liver panel laboratory parameters: ALT, AST, alkaline phosphatase, total bilirubin, Direct bilirubin, and INR | Baseline (Day -28) up to Day 21 |
| Maximum plasma concentration at steady state (Cmax,ss) for VH4524184 | Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis. | On Day 20 |
| Time to maximum concentration at steady state (Tmax, ss) during dosing interval for VH4524184 | Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis. | On Day 20 |
| Area under the concentration-time curve from time zero(pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) for VH4524184 | Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis. | On Day 20 |
| Trough concentration prior to the next dose (Ctrough) for VH4524184 | Blood samples will be collected at indicated timepoints for plasma VH4524184 PK analysis. | On Day 12, Day 16, and Day 20 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |