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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID: NCT06310616
Run by: ViiV Healthcare
People needed: 26
Starts: 2024-03-06
Expected to finish: 2024-08-15
Last updated by the study team: 2024-12-10

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.
Prior/Concomitant Therapy
Any warnings and contraindications that apply based on Loestrin prescribing information.
Prior/Concurrent Clinical Study Experience
Exposure to more than 4 new investigational products (including long-acting investigational products) within 12 months prior to the first dosing day.
Current enrollment or past participation in another investigational study in which an investigational intervention was administered within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) before signing of consent (or screening) any other clinical study.
Participant has donated or lost blood (>500 millilitres (mL)) or blood products within 2 months (56-day period) prior to Day -1 admission or has donated plasma within 30 days prior to first OC administration.
Current enrollment or past participation in this clinical study. Unwillingness or inability to follow the procedures outlined in the protocol.
Positive Human immunodeficiency virus 1 (HIV-1) antibody test.
Pregnant at screening) or lactating.
POCBP who are unwilling or unable to use an appropriate non-hormonal method of highly effective contraception from at least Day 1 of Treatment Period 1 until 14 days after the last dose of VH4524184.
Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of >7 units for females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (\~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Regular use of known drugs of abuse.

Where it is running

GSK Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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