GSK Investigational Site
San Antonio, Texas, 78209, United States
NCT Number: NCT06310616
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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Notify Me18 year–45 year
Female
Interventional
Phase 1
San Antonio, Texas, 78209, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prior/Concomitant Therapy
Prior/Concurrent Clinical Study Experience
VH4524184 will be administered.
Loestrin will be administered.
Time frame: On Day 10
Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.
Time frame: On Day 20
Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.
Time frame: On Day 10
Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.
Time frame: On Day 20
Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.
Time frame: From Day -28 (Run-In-Period) up to approximately 2 months (Day 28 +/- 3 days)
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: Throughout the study treatment period (from Day -28 up to Day 20)
Time frame: Baseline (Day -28) up to Day 21
Time frame: Baseline (Day -28) up to Day 21
Time frame: Baseline (Day -28) up to Day 21
Time frame: Baseline (Day -28) up to Day 21
Time frame: On Day 20
Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis.
Time frame: On Day 20
Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis.
Time frame: On Day 20
Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis.
Time frame: On Day 12, Day 16, and Day 20
Blood samples will be collected at indicated timepoints for plasma VH4524184 PK analysis.
ViiV Healthcare
Industry
A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics of Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol (Loestrin) When Co-administered With VH4524184 in Healthy Adult Female Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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