Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
2026年6月29日 更新者: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.
調査の概要
研究の種類
介入
入学 (推定)
9
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:US GSK Clinical Trials Call Center
- 電話番号:877-379-3718
- メール:GSKClinicalSupportHD@gsk.com
研究連絡先のバックアップ
- 名前:EU GSK Clinical Trials Call Center
- 電話番号:+44 (0) 20 89904466
- メール:GSKClinicalSupportHD@gsk.com
研究場所
-
-
-
Groningen、オランダ、9728 NZ
- 募集
- GSK Investigational Site
-
コンタクト:
- US GSK Clinical Trials Call Center
- 電話番号:877-379-3718
- メール:GSKClinicalSupportHD@gsk.com
-
コンタクト:
- EU GSK Clinical Trials Call Centre
- 電話番号:+44 (0) 20 8990 4466
- メール:GSKClinicalSupportHD@gsk.com
-
主任研究者:
- Renger Tiessen
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:基礎科学
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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.
|
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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Absolute bioavailability (F oral) of VH4524184 (Period 1)
時間枠: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)
時間枠:Day 1 up to Day 14
|
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)
時間枠: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)
時間枠:Day 1 up to Day 14
|
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)
時間枠: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).
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Day 15 up to Day 43
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Amount of TRA excreted in vomitus (Ae vomit) (Period 1)
時間枠:At Day 1
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At Day 1
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Amount of TRA excreted in vomitus (Ae vomit) (Period 2)
時間枠:At Day 15
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At Day 15
|
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Total amount of TRA excreted (Ae total) (Period 1)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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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Fraction of TRA excreted in feces (fe feces) (Period 1)
時間枠: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).
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Day 1 up to Day 14
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Fraction of TRA excreted in feces (fe feces) (Period 2)
時間枠: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).
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Day 15 up to Day 43
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Fraction of TRA excreted in vomitus (fe vomit) (Period 1)
時間枠:At Day 1
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At Day 1
|
|
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Fraction of TRA excreted in vomitus (fe vomit) (Period 2)
時間枠:At Day 15
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At Day 15
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Total fraction of TRA excreted (fe total) (Period 1)
時間枠: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).
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Day 1 up to Day 14
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Total fraction of TRA excreted (fe total) (Period 2)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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 2)
時間枠: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)
時間枠:Day 1 to Day 14
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Day 1 to Day 14
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|
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Time to maximum concentration (tmax) of TRA in whole blood (Period 2)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠:Day 1 to Day 14
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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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠:Day 15 to Day 43
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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)
時間枠: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)
時間枠: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)
時間枠:Day 1 to Day 14
|
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)
時間枠: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)
時間枠:Day 15 to 43
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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)
時間枠: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)
時間枠:Day 15 to Day 43
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Day 15 to Day 43
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Amount of VH4524184 excreted in urine (Ae urine) (Period 2)
時間枠:Day 15 to Day 43
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Day 15 to Day 43
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|
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Fraction of VH4524184 excreted in urine (fe urine) (Period 2)
時間枠: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)
時間枠:Day 15 to Day 43
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Day 15 to Day 43
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of participants with adverse events (AE), overall and by severity (Periods 1 and 2)
時間枠:Day 1 to Day 50
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Day 1 to Day 50
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Number of participants who discontinue treatment due to AEs (Periods 1 and 2)
時間枠: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)
時間枠:On Days 2, 14, 16, 28 and 42
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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)
時間枠: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)
時間枠: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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年6月4日
一次修了 (推定)
2026年8月20日
研究の完了 (推定)
2026年8月20日
試験登録日
最初に提出
2026年5月29日
QC基準を満たした最初の提出物
2026年6月3日
最初の投稿 (実際)
2026年6月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月2日
QC基準を満たした最後の更新が送信されました
2026年6月29日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 223803
- 2026-525590-40 (その他の識別子:EU CT Number)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。