- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07636928
Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
29 czerwca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Rekrutacyjny
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
9
Faza
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: US GSK Clinical Trials Call Center
- Numer telefonu: 877-379-3718
- E-mail: GSKClinicalSupportHD@gsk.com
Kopia zapasowa kontaktu do badania
- Nazwa: EU GSK Clinical Trials Call Center
- Numer telefonu: +44 (0) 20 89904466
- E-mail: GSKClinicalSupportHD@gsk.com
Lokalizacje studiów
-
-
-
Groningen, Holandia, 9728 NZ
- Rekrutacyjny
- GSK Investigational Site
-
Kontakt:
- US GSK Clinical Trials Call Center
- Numer telefonu: 877-379-3718
- E-mail: GSKClinicalSupportHD@gsk.com
-
Kontakt:
- EU GSK Clinical Trials Call Centre
- Numer telefonu: +44 (0) 20 8990 4466
- E-mail: GSKClinicalSupportHD@gsk.com
-
Główny śledczy:
- Renger Tiessen
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Absolute bioavailability (F oral) of VH4524184 (Period 1)
Ramy czasowe: 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)
Ramy czasowe: 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).
|
Day 1 up to Day 14
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Amount of TRA excreted in urine (Ae urine) (Period 2)
Ramy czasowe: Day 15 up to Day 43
|
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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Amount of TRA excreted in feces (Ae feces) (Period 1)
Ramy czasowe: 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).
|
Day 1 up to Day 14
|
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Amount of TRA excreted in feces (Ae feces) (Period 2)
Ramy czasowe: Day 15 up to Day 43
|
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 15 up to Day 43
|
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Amount of TRA excreted in vomitus (Ae vomit) (Period 1)
Ramy czasowe: At Day 1
|
At Day 1
|
|
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Amount of TRA excreted in vomitus (Ae vomit) (Period 2)
Ramy czasowe: At Day 15
|
At Day 15
|
|
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Total amount of TRA excreted (Ae total) (Period 1)
Ramy czasowe: 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)
Ramy czasowe: 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).
|
Day 15 up to Day 43
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Fraction of TRA excreted in urine (fe urine) (Period 1)
Ramy czasowe: Day 1 up to Day 14
|
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).
|
Day 1 up to Day 14
|
|
Fraction of TRA excreted in urine (fe urine) (Period 2)
Ramy czasowe: Day 15 up to Day 43
|
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
|
|
Fraction of TRA excreted in feces (fe feces) (Period 1)
Ramy czasowe: Day 1 up to Day 14
|
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
|
|
Fraction of TRA excreted in feces (fe feces) (Period 2)
Ramy czasowe: Day 15 up to Day 43
|
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 15 up to Day 43
|
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Fraction of TRA excreted in vomitus (fe vomit) (Period 1)
Ramy czasowe: At Day 1
|
At Day 1
|
|
|
Fraction of TRA excreted in vomitus (fe vomit) (Period 2)
Ramy czasowe: At Day 15
|
At Day 15
|
|
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Total fraction of TRA excreted (fe total) (Period 1)
Ramy czasowe: Day 1 up to Day 14
|
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)
Ramy czasowe: Day 15 up to Day 43
|
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).
|
Day 15 up to Day 43
|
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Maximum concentration (Cmax) of VH4524184 in plasma (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
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Maximum concentration (Cmax) of VH4524184 in plasma (Period 2)
Ramy czasowe: Day 15 to Day 43
|
Day 15 to Day 43
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Maximum concentration (Cmax) of [14C]VH4524184 in plasma (Period 1)
Ramy czasowe: 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)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
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Maximum concentration (Cmax) of TRA in plasma (Period 2)
Ramy czasowe: 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)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
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Cmax of TRA in whole blood (Period 2)
Ramy czasowe: Day 15 to Day 43
|
Day 15 to Day 43
|
|
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Time to maximum concentration (tmax) of VH4524184 in plasma (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
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Time to maximum concentration (tmax) of VH4524184 in plasma (Period 2)
Ramy czasowe: Day 15 to Day 43
|
Day 15 to Day 43
|
|
|
Time to maximum concentration (tmax) of [14C]VH4524184 in plasma (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Time to maximum concentration (tmax) of TRA in plasma (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Time to maximum concentration (tmax) of TRA in plasma (Period 2)
Ramy czasowe: Day 15 to Day 43
|
Day 15 to Day 43
|
|
|
Time to maximum concentration (tmax) of TRA in whole blood (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Time to maximum concentration (tmax) of TRA in whole blood (Period 2)
Ramy czasowe: 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 VH4524184 in plasma (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 2)
Ramy czasowe: Day 15 to Day 43
|
Day 15 to Day 43
|
|
|
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of [14C]VH4524184 in plasma (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in plasma (Period 2)
Ramy czasowe: Day 15 to Day 43
|
Day 15 to Day 43
|
|
|
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of TRA in whole blood (Period 2)
Ramy czasowe: Day 15 to Day 43
|
Day 15 to Day 43
|
|
|
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of VH4524184 in plasma (Period 2)
Ramy czasowe: Day 15 up to Day 43
|
Day 15 up to Day 43
|
|
|
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of [14C]VH4524184 in plasma (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in plasma (Period 2)
Ramy czasowe: Day 15 to 43
|
Day 15 to 43
|
|
|
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 1)
Ramy czasowe: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Area under the concentration-time curve from time zero to infinity (AUC 0-inf) of TRA in whole blood (Period 2)
Ramy czasowe: Day 15 to Day 43
|
Day 15 to Day 43
|
|
|
Amount of VH4524184 excreted in urine (Ae urine) (Period 2)
Ramy czasowe: Day 15 to Day 43
|
Day 15 to Day 43
|
|
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Fraction of VH4524184 excreted in urine (fe urine) (Period 2)
Ramy czasowe: Day 15 to Day 43
|
Day 15 to Day 43
|
|
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Renal clearance of VH4524184 (CL R) (Period 2)
Ramy czasowe: Day 15 to Day 43
|
Day 15 to Day 43
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of participants with adverse events (AE), overall and by severity (Periods 1 and 2)
Ramy czasowe: 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)
Ramy czasowe: Day 1 to Day 50
|
Day 1 to Day 50
|
|
|
Change from baseline for aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Ramy czasowe: On Days 2, 14, 16, 28 and 42
|
On Days 2, 14, 16, 28 and 42
|
|
|
Maximum toxicity grade increase from baseline for AST, ALT, total bilirubin, and alkaline phosphatase (Periods 1 and 2)
Ramy czasowe: On Days 2, 14, 16, 28 and 42
|
On Days 2, 14, 16, 28 and 42
|
|
|
Blood to plasma ratio of TRA (Periods 1 and 2)
Ramy czasowe: Day 1 to Day 14 (Period 1) and Day 15 to Day 28 (Period 2)
|
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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
4 czerwca 2026
Zakończenie podstawowe (Szacowany)
20 sierpnia 2026
Ukończenie studiów (Szacowany)
20 sierpnia 2026
Daty rejestracji na studia
Pierwszy przesłany
29 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
3 czerwca 2026
Pierwszy wysłany (Rzeczywisty)
9 czerwca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
2 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
29 czerwca 2026
Ostatnia weryfikacja
1 czerwca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Infekcje przenoszone przez krew
- Choroby układu moczowo-płciowego
- Choroby narządów płciowych
- Choroby układu odpornościowego
- Infekcje
- Zakażenia wirusem RNA
- Choroby wirusowe
- Choroby zakaźne
- Choroby przenoszone drogą płciową, wirusowe
- Choroby przenoszone drogą płciową
- Infekcje lentiwirusowe
- Zakażenia Retroviridae
- Zespoły niedoboru odporności
- Powolne choroby wirusowe
- Zakażenia wirusem HIV
- Zespół nabytego niedoboru odporności
Inne numery identyfikacyjne badania
- 223803
- 2026-525590-40 (Inny identyfikator: EU CT Number)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
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
Ramy czasowe udostępniania IPD
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.
Kryteria dostępu do udostępniania IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Tak
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Tak
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .