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

NCT06310616 | Completed Phase 1 FDA Drug

• 1 other identifier: 219888
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

  Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

  On Day 10

• AUC0-Tau, ss of EE and NEA with coadministration with VH4524184

  Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

  On Day 20

• Maximum plasma concentration (Cmax) for EE and NEA without coadministration with VH4524184

  Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

  On Day 10

• Cmax for EE and NEA with coadministration with VH4524184

  Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.

  On Day 20

Secondary Outcomes (10)

• Number of participants with adverse events (AEs) and severity of AEs

  From Day -28 (Run-In-Period) up to approximately 2 months (Day 28 +/- 3 days)

• Number of participants with AEs leading to discontinuation of study intervention

  Throughout the study treatment period (from Day -28 up to Day 20)

• Change from baseline of liver panel laboratory parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ASP) (International units per liter)

  Baseline (Day -28) up to Day 21

• Change from baseline of liver panel laboratory parameters: Total bilirubin, Direct bilirubin (Micromoles per liter [umol/L])

  Baseline (Day -28) up to Day 21

• Change from baseline of liver panel laboratory parameters: International normalized ratio (INR) (Ratio)

  Baseline (Day -28) up to Day 21

Study Arms (1)

Loestrin + VH4524184

EXPERIMENTAL

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.

Drug: VH4524184; Drug: Loestrin

Interventions

VH4524184 DRUG

VH4524184 will be administered.

Loestrin + VH4524184

Loestrin DRUG

Loestrin will be administered.

Loestrin + VH4524184

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female participants of childbearing potential (POCBP)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• ViiV Healthcare: lead

Study Sites (1)

GSK Investigational Site

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 15, 2024
• Study Start: March 6, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

US (1)