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HIV InfectionsPhase 1NCT06310616

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

A Phase 1 study testing VH4524184 and Loestrin in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
VH4524184 and Loestrin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
6 Mar 2024to 15 Aug 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    San Antonio, Texas, 78209

Other trials in United States

About this study

Official title: 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.

Conditions
HIV Infections
Being tested
VH4524184, Loestrin
Keywords
HIV, Oral contraceptive, Pharmacokinetic, Ethinyl estradiol, Norethindrone acetate, Potential drug-drug interaction, Healthy adult female participants
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VH4524184Drug

    VH4524184 will be administered.

  • LoestrinDrug

    Loestrin will be administered.

Study groups in NCT06310616
Study groupRoleWhat they receive
Loestrin + VH4524184ExperimentalEligible 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.
Receives: Drug: VH4524184; Drug: Loestrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: On Day 10

  2. 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.

    Measured: On Day 20

  3. 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.

    Measured: On Day 10

  4. Cmax for EE and NEA with coadministration with VH4524184

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

    Measured: On Day 20

Secondary outcomes (10)

  1. Number of participants with adverse events (AEs) and severity of AEs

    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.

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

  2. Number of participants with AEs leading to discontinuation of study intervention

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

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

    Measured: Baseline (Day -28) up to Day 21

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

    Measured: Baseline (Day -28) up to Day 21

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

    Measured: Baseline (Day -28) up to Day 21

  6. 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

    Measured: Baseline (Day -28) up to Day 21

  7. Maximum plasma concentration at steady state (Cmax,ss) for VH4524184

    Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis.

    Measured: On Day 20

  8. Time to maximum concentration at steady state (Tmax, ss) during dosing interval for VH4524184

    Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis.

    Measured: On Day 20

  9. 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

    Blood samples will be collected at indicated timepoint for plasma VH4524184 PK analysis.

    Measured: On Day 20

  10. Trough concentration prior to the next dose (Ctrough) for VH4524184

    Blood samples will be collected at indicated timepoints for plasma VH4524184 PK analysis.

    Measured: On Day 12, Day 16, and Day 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start6 Mar 2024
  3. Primary completion15 Aug 2024
  4. Study completion15 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06310616
Sponsor's protocol ID
219888
Status last verified
Dec 2024
First submitted
1 Mar 2024
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VH4524184 and Loestrin in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06310616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.

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