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A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants - Trial NCT06310616

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.

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NCT06310616
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06310616
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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

Study Focus

HIV Infections

VH4524184

Interventional

drug

Sponsor & Location

ViiV Healthcare

San Antonio, United States of America

Timeline & Enrollment

Phase 1

Mar 06, 2024

May 28, 2024

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 infections
HIV disease resulting in other bacterial infections
HIV disease resulting in multiple infections
Acute HIV infection syndrome
HIV disease resulting in other infectious and parasitic diseases

Data Source

ClinicalTrials.gov

NCT06310616

Non-Device Trial