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

NCT ID: NCT06310616

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-06
• Study Completion Date: 2024-08-15

Brief 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.

Conditions

HIV Infections

Keywords

HIV; Oral contraceptive; Pharmacokinetic; Ethinyl estradiol; Norethindrone acetate; Potential drug-drug interaction; Healthy adult female participants

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Loestrin + VH4524184

Eligible participants entering a run-in period of 21 days (Days -28 through -8) will receive Loestrin (EE and NEA) to stabilize on the combined OCs containing EE and NEA to synchronize the menstrual cycles of multiple participants. Participants completing the run-in period will enter Treatment Period 1 and will be administered Loestrin once daily from Days 1 to 10. On Day 11, participants will enter Treatment Period 2 and will be administered Loestrin + VH4524184 once daily from Days 11 to 20.

Group Type: EXPERIMENTAL

VH4524184

Intervention Type: DRUG

VH4524184 will be administered.

Loestrin

Intervention Type: DRUG

Loestrin will be administered.

Interventions

VH4524184

VH4524184 will be administered.

Intervention Type: DRUG

Loestrin

Loestrin will be administered.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ViiV Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

San Antonio, Texas, United States

Countries

United States

Other Identifiers

219888

Identifier Type: -

Identifier Source: org_study_id