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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
GSK Investigational Site
San Antonio, Texas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: On Day 20
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.
Time frame: From Day -28 (Run-In-Period) up to approximately 2 months (Day 28 +/- 3 days)
Number of participants with AEs leading to discontinuation of study intervention
Time frame: 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)
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Time frame: Baseline (Day -28) up to Day 21
Change from baseline of liver panel laboratory parameters: Total bilirubin, Direct bilirubin (Micromoles per liter [umol/L])
Time frame: Baseline (Day -28) up to Day 21
Change from baseline of liver panel laboratory parameters: International normalized ratio (INR) (Ratio)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: On Day 12, Day 16, and Day 20