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

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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

NCT06310616•ViiV Healthcare

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy participants 18 to 45 years of age
•POCBP with intact ovarian function by medical history and history of regular menstrual cycles for the past 12
•Body weight greater than or equal to (≥) 45 kilograms (kg) and Body mass index (BMI) within the range of 18.5 to 32.0 kg/m2
•Female participants of childbearing potential must use approved highly effective non-hormonal forms of birth control.
•Capable of giving signed informed consent.

Exclusion Criteria

•History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs.
•Lymphoma, leukemia, or any malignancy within the past 5 years with some exceptions
•Breast cancer or in remission within the past 10 years.
•Current or chronic history of liver disease or known hepatic or biliary abnormalities with some exceptions.
•Any personal and/or family history of thrombophilia or blood clots
•Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.
•History of seizure(s).
•Any known or suspected pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances.
•Subjects with history of drug hypersensitivity, delayed-type hypersensitivity, or severe hypersensitivity reactions, as well as history of sensitivity to the study interventions will be excluded.
•Participant is mentally or legally incapacitated.
+12 more criteria

Locations (1)

GSK Investigational Site

San Antonio, Texas, United States

Key Dates

Start Date

March 6, 2024

Primary Completion Date

August 15, 2024

Completion Date

August 15, 2024

Last Updated

December 10, 2024

Enrollment

ACTUAL participants

Conditions

HIV Infections

Interventions

VH4524184

DRUG

Loestrin

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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