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NCT06310616

A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants

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
ViiV Healthcare·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
HIV Infections
Drug/Device/Intervention
VH4524184
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
ViiV Healthcare
Location
San Antonio, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Mar 06, 2024
End date
May 28, 2024
Enrollment
25 participants
Primary outcome

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,AUC0-Tau, ss of EE and NEA with coadministration with VH4524184,Maximum plasma concentration (Cmax) for EE and NEA without coadministration with VH4524184,Cmax for EE and NEA with coadministration with VH4524184

Summary

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.

ICD-10 classifications
HIV disease resulting in other viral infectionsHIV disease resulting in other bacterial infectionsHIV disease resulting in multiple infectionsAcute HIV infection syndromeHIV disease resulting in other infectious and parasitic diseases
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06310616
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06310616 through Pure Global AI's free database. This Phase 1 trial is sponsored by ViiV Healthcare and is currently Recruiting. The study focuses on HIV Infections. Target enrollment is 25 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.