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NCT06310616CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 10 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
26 (actual)
First submitted
1 Mar 2024
Start date
6 Mar 2024
Primary completion date
15 Aug 2024
Lead sponsor
ViiV Healthcare
Diseases
HIV
NCT number
NCT06310616

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 26
  • From 6 Mar 2024 to the primary completion date, 15 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • 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
  • 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.
  • Positive Human immunodeficiency virus 1 (HIV-1) antibody test.

Lab values

  • Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.

Other

  • Current enrollment or past participation in this clinical study. Unwillingness or inability to follow the procedures outlined in the protocol.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 45 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.