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

December 9, 2024 updated by: ViiV Healthcare

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78209
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: VH4524184
VH4524184 will be administered.
Drug: Loestrin
Loestrin will be administered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: On Day 10
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
Time Frame: On Day 20
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
Time Frame: On Day 10
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
Time Frame: On Day 20
Blood samples will be collected at indicated timepoint for plasma EE and NEA PK analysis.
On Day 20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events (AEs) and severity of AEs
Time Frame: From Day -28 (Run-In-Period) up to approximately 2 months (Day 28 +/- 3 days)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
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
Time Frame: Throughout the study treatment period (from Day -28 up to Day 20)
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)
Time Frame: Baseline (Day -28) up to Day 21
Baseline (Day -28) up to Day 21
Change from baseline of liver panel laboratory parameters: Total bilirubin, Direct bilirubin (Micromoles per liter [umol/L])
Time Frame: Baseline (Day -28) up to Day 21
Baseline (Day -28) up to Day 21
Change from baseline of liver panel laboratory parameters: International normalized ratio (INR) (Ratio)
Time Frame: Baseline (Day -28) up to Day 21
Baseline (Day -28) up to Day 21
Number of participants with maximum toxicity grade increase from baseline of liver panel laboratory parameters: ALT, AST, alkaline phosphatase, total bilirubin, Direct bilirubin, and INR
Time Frame: Baseline (Day -28) up to Day 21
Baseline (Day -28) up to Day 21
Maximum plasma concentration at steady state (Cmax,ss) for VH4524184
Time Frame: On Day 20
Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis.
On Day 20
Time to maximum concentration at steady state (Tmax, ss) during dosing interval for VH4524184
Time Frame: On Day 20
Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis.
On Day 20
Area under the concentration-time curve from time zero(pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) for VH4524184
Time Frame: On Day 20
Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis.
On Day 20
Trough concentration prior to the next dose (Ctrough) for VH4524184
Time Frame: On Day 12, Day 16, and Day 20
Blood samples will be collected at indicated timepoints for plasma VH4524184 PK analysis.
On Day 12, Day 16, and Day 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ViiV Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 219888

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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