- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07636928
Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
29. juni 2026 oppdatert av: ViiV Healthcare
A Phase 1, Open-Label, Single Dose Study to Assess the Absolute Bioavailability, Mass Balance, Pharmacokinetics, Metabolism, and Excretion of [14C]VH4524184 in Healthy Participants
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
9
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: US GSK Clinical Trials Call Center
- Telefonnummer: 877-379-3718
- E-post: GSKClinicalSupportHD@gsk.com
Studer Kontakt Backup
- Navn: EU GSK Clinical Trials Call Center
- Telefonnummer: +44 (0) 20 89904466
- E-post: GSKClinicalSupportHD@gsk.com
Studiesteder
-
-
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Groningen, Nederland, 9728 NZ
- Rekruttering
- GSK Investigational Site
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Ta kontakt med:
- US GSK Clinical Trials Call Center
- Telefonnummer: 877-379-3718
- E-post: GSKClinicalSupportHD@gsk.com
-
Ta kontakt med:
- EU GSK Clinical Trials Call Centre
- Telefonnummer: +44 (0) 20 8990 4466
- E-post: GSKClinicalSupportHD@gsk.com
-
Hovedetterforsker:
- Renger Tiessen
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Willing and able to sign the Informed Consent Form (ICF).
- Sex at birth: male or female; female participants must be of non-childbearing potential, or postmenopausal.
- Age: 18 to 55 years, inclusive, at screening.
- BMI: 18.0 to 32.0 kg/m^2, inclusive, at screening.
- Female participants of non-childbearing potential must have unequivocal documentation that they are not of childbearing potential Postmenopausal female participants must have a serum follicle-stimulating hormone (FSH) concentration >33.4 milli-international units per milliliter (mIU/mL) at screening to confirm menopause.
- Male participants, if not surgically sterilized and who have a female partner of childbearing potential, must agree to use a condom during any sexual intercourse until the completion of the follow-up visit.
- Male participants must agree not to donate sperm from admission on Day -1 until the completion of the follow-up visit.
- All prescribed medication must have been stopped at least 30 days and >5 half-lives prior to admission to the clinical site on Day -1.
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications must have been stopped at least 14 days prior to admission to the clinical site on Day -1. An exception is made for paracetamol that is allowed up to admission to the clinical site on Day -1.
- Ability and willingness to abstain from alcohol from 48 hours prior to screening and admission to the clinical site on Day -1 until the last PK sample.
- Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, black tea, green tea, white tea, cola, chocolate, energy drinks), and grapefruit (juice) from 48 hours prior to admission to the clinical site.
- Good physical and mental health based on medical history, physical examination, clinical laboratory, electrocardiogram (ECG), and vital signs, as judged by the Investigator.
Exclusion Criteria:
- Employee of ICON, the Sponsor, GSK or associated vendors.
- History of relevant drug and/or food allergies.
- History of drug hypersensitivity, delayed-type hypersensitivity, or severe hypersensitivity reactions, as well as history of sensitivity to the study drug.
- Using tobacco/nicotine products within 60 days prior to the first study drug administration.
- History of alcohol abuse or drug addiction within 5 years prior to screening.
- Positive drug and/or alcohol screen at screening or admission to the clinical site.
- Average intake of more than 24 units of alcohol per week.
- Positive screen for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) 1 and 2 antibodies at screening.
- Participation in a drug study with a small molecule drug within 30 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in a clinical study with a biological within 90 days or 5 half-lives if known (whichever is longer) prior to the first study drug administration in the current study. Participation in 4 or more other drug studies in the 12 months prior to the first study drug administration in the current study.
- Donation or loss of more than 450 mL of blood within 60 days prior to the first study drug administration. Donation or loss of more than 1.5 L of blood (for male participants)/more than 1.0 L of blood (for female participants) in the 10 months prior to the first study drug administration in the current study.
- Significant and/or acute illness within 14 days prior to the first study drug administration that may impact safety assessments, in the opinion of the Investigator.
- Any significant current/ongoing known or suspected pre-existing psychiatric condition, including depression, anxiety, and/or insomnia/sleep disturbances and/or suicidal ideation, in the opinion of the Investigator.
- Unsuitable veins for infusion or blood sampling.
- Participation in a study with a 14C dose of ≥0.1 megabecquerel (MBq) in the period of 1 year prior to screening.
- Irregular defecation pattern.
- Pre-existing clinically relevant, in the opinion of the Investigator in discussion with the Sponsor medical monitor, gastro-intestinal pathology or diagnosis, eg, irritable bowel syndrome, inflammatory bowel disease, and/or significant baseline signs and symptoms.
- History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drugs, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits, in the opinion of the Investigator. The Investigator may contact the Sponsor medical monitor to discuss the inclusion of participants who have a history of specific conditions that are not expected to interfere with their participation in the study.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: VH4524184 Group
Participants will receive a dose of VH4524184 under fasting conditions, followed by a microdose of radiolabelled [14C]VH4524184 administered 2.5 hours after first dose administration at time zero on Day 1 (Period1).
After a 14 days wash-out period participants will receive a radiolabelled dose of [14C]VH4524184 on Day 15 under fasting conditions.
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One dose of VH4524184 is administered to participants at time zero on Day 1 (Period 1).
A radiolabelled microdose of [14C]VH4524184 is administered 2.5 hours after VH4524184 dose administration on Day 1 (Period1).
One dose of radiolabelled [14C]VH4524184 is administered to participants at Day 15 (Period 2).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Absolute bioavailability (F oral) of VH4524184 (Period 1)
Tidsramme: Day 1 up to Day 14
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Day 1 up to Day 14
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Amount of total radioactivity (TRA) excreted in urine (Ae urine) (Period 1)
Tidsramme: Day 1 up to Day 14
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Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 1 up to Day 14
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Amount of TRA excreted in urine (Ae urine) (Period 2)
Tidsramme: Day 15 up to Day 43
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Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 15 up to Day 43
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Amount of TRA excreted in feces (Ae feces) (Period 1)
Tidsramme: Day 1 up to Day 14
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Feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 1 up to Day 14
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Amount of TRA excreted in feces (Ae feces) (Period 2)
Tidsramme: Day 15 up to Day 43
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Feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 15 up to Day 43
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Amount of TRA excreted in vomitus (Ae vomit) (Period 1)
Tidsramme: At Day 1
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At Day 1
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Amount of TRA excreted in vomitus (Ae vomit) (Period 2)
Tidsramme: At Day 15
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At Day 15
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Total amount of TRA excreted (Ae total) (Period 1)
Tidsramme: From Day 1 up to Day 14
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The Ae of TRA measured in urine, feces and vomitus (if applicable on Day 1 only).
Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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From Day 1 up to Day 14
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Total amount of TRA excreted (Ae total) (Period 2)
Tidsramme: Day 15 up to Day 43
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The Ae of TRA measured in urine, feces and vomitus (if applicable on Day 15 only).
Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 15 up to Day 43
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Fraction of TRA excreted in urine (fe urine) (Period 1)
Tidsramme: Day 1 up to Day 14
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Urine is collected until the amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 1 up to Day 14
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Fraction of TRA excreted in urine (fe urine) (Period 2)
Tidsramme: Day 15 up to Day 43
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Urine is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
|
Day 15 up to Day 43
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Fraction of TRA excreted in feces (fe feces) (Period 1)
Tidsramme: Day 1 up to Day 14
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Feces is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
|
Day 1 up to Day 14
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Fraction of TRA excreted in feces (fe feces) (Period 2)
Tidsramme: Day 15 up to Day 43
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Feces is collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 15 up to Day 43
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Fraction of TRA excreted in vomitus (fe vomit) (Period 1)
Tidsramme: At Day 1
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At Day 1
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Fraction of TRA excreted in vomitus (fe vomit) (Period 2)
Tidsramme: At Day 15
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At Day 15
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Total fraction of TRA excreted (fe total) (Period 1)
Tidsramme: Day 1 up to Day 14
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The fe of TRA measured in urine, feces and vomitus (if applicable on Day 1 only).
Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
|
Day 1 up to Day 14
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Total fraction of TRA excreted (fe total) (Period 2)
Tidsramme: Day 15 up to Day 43
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The fe of TRA measured in urine, feces and vomitus (if applicable on Day 15 only).
Urine and feces are collected until amount of radioactivity recovered in excreta (urine and feces) is at least 90% of administered radioactivity and <1% has been recovered from excreta from 2 consecutive days (ie, the total for urine and feces is <1% on 2 consecutive days).
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Day 15 up to Day 43
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Maximum concentration (Cmax) of VH4524184 in plasma (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Maximum concentration (Cmax) of VH4524184 in plasma (Period 2)
Tidsramme: Day 15 to Day 43
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Day 15 to Day 43
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Maximum concentration (Cmax) of [14C]VH4524184 in plasma (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Maximum concentration (Cmax) of TRA in plasma (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Maximum concentration (Cmax) of TRA in plasma (Period 2)
Tidsramme: Day 15 to Day 43
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Day 15 to Day 43
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Cmax of TRA in whole blood (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Cmax of TRA in whole blood (Period 2)
Tidsramme: Day 15 to Day 43
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Day 15 to Day 43
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Time to maximum concentration (tmax) of VH4524184 in plasma (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Time to maximum concentration (tmax) of VH4524184 in plasma (Period 2)
Tidsramme: Day 15 to Day 43
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Day 15 to Day 43
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|
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Time to maximum concentration (tmax) of [14C]VH4524184 in plasma (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Time to maximum concentration (tmax) of TRA in plasma (Period 1)
Tidsramme: Day 1 to Day 14
|
Day 1 to Day 14
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Time to maximum concentration (tmax) of TRA in plasma (Period 2)
Tidsramme: Day 15 to Day 43
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Day 15 to Day 43
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Time to maximum concentration (tmax) of TRA in whole blood (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
|
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Time to maximum concentration (tmax) of TRA in whole blood (Period 2)
Tidsramme: Day 15 to Day 43
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Day 15 to Day 43
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 2)
Tidsramme: Day 15 to Day 43
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Day 15 to Day 43
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of [14C]VH4524184 in plasma (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 1)
Tidsramme: Day 1 to Day 14
|
Day 1 to Day 14
|
|
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 2)
Tidsramme: Day 15 to Day 43
|
Day 15 to Day 43
|
|
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 1)
Tidsramme: Day 1 to Day 14
|
Day 1 to Day 14
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Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 2)
Tidsramme: Day 15 to Day 43
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Day 15 to Day 43
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 2)
Tidsramme: Day 15 up to Day 43
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Day 15 up to Day 43
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of [14C]VH4524184 in plasma (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 2)
Tidsramme: Day 15 to 43
|
Day 15 to 43
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 1)
Tidsramme: Day 1 to Day 14
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Day 1 to Day 14
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Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 2)
Tidsramme: Day 15 to Day 43
|
Day 15 to Day 43
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Amount of VH4524184 excreted in urine (Ae urine) (Period 2)
Tidsramme: Day 15 to Day 43
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Day 15 to Day 43
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Fraction of VH4524184 excreted in urine (fe urine) (Period 2)
Tidsramme: Day 15 to Day 43
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Day 15 to Day 43
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Renal clearance of VH4524184 (CL R) (Period 2)
Tidsramme: Day 15 to Day 43
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Day 15 to Day 43
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with adverse events (AE), overall and by severity (Periods 1 and 2)
Tidsramme: Day 1 to Day 50
|
Day 1 to Day 50
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Number of participants who discontinue treatment due to AEs (Periods 1 and 2)
Tidsramme: Day 1 to Day 50
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Day 1 to Day 50
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Change from baseline for aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Tidsramme: On Days 2, 14, 16, 28 and 42
|
On Days 2, 14, 16, 28 and 42
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Maximum toxicity grade increase from baseline for AST, ALT, total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Tidsramme: On Days 2, 14, 16, 28 and 42
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On Days 2, 14, 16, 28 and 42
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Blood to plasma ratio of TRA (Periods 1 and 2)
Tidsramme: Day 1 to Day 14 (Period 1) and Day 15 to Day 28 (Period 2)
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Cmax, AUC(0-t) and AUC(0-inf) TRA measured in whole blood compared to Cmax, AUC(0-t) and AUC(0-inf) TRA measured in plasma in Period 1 and Period 2.
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Day 1 to Day 14 (Period 1) and Day 15 to Day 28 (Period 2)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
4. juni 2026
Primær fullføring (Antatt)
20. august 2026
Studiet fullført (Antatt)
20. august 2026
Datoer for studieregistrering
Først innsendt
29. mai 2026
Først innsendt som oppfylte QC-kriteriene
3. juni 2026
Først lagt ut (Faktiske)
9. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Blodbårne infeksjoner
- Urogenitale sykdommer
- Kjønnssykdommer
- Sykdommer i immunsystemet
- Infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Smittsomme sykdommer
- Seksuelt overførbare sykdommer, virale
- Seksuelt overførbare sykdommer
- Lentivirus infeksjoner
- Retroviridae-infeksjoner
- Immunologiske mangelsyndromer
- Langsomme virussykdommer
- HIV-infeksjoner
- Ervervet immunsviktsyndrom
Andre studie-ID-numre
- 223803
- 2026-525590-40 (Annen identifikator: EU CT Number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents.
Data sharing is subject to certain criteria, conditions, and exceptions.
For further information, refer to https://www.viiv-studyregister.com/documents/About_ViiV_Patient_Level_Data_Sharing_Final_25Sep2023.pdf
IPD-delingstidsramme
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 asset(s) with development terminated across all indications.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .