Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525590-40 | Other Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to assess the bioavailability, mass balance, pharmacokinetics, metabolism and excretion of radiolabeled (14C) VH4524184.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VH4524184 Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VH4524184 | Drug | One dose of VH4524184 is administered to participants at time zero on Day 1 (Period 1). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute bioavailability (F oral) of VH4524184 (Period 1) | Day 1 up to Day 14 | |
| Amount of total radioactivity (TRA) excreted in urine (Ae urine) (Period 1) | 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 |
| Amount of TRA excreted in urine (Ae urine) (Period 2) | 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 |
| Amount of TRA excreted in feces (Ae feces) (Period 1) | 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 |
| Amount of TRA excreted in feces (Ae feces) (Period 2) | 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 |
| Amount of TRA excreted in vomitus (Ae vomit) (Period 1) | At Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AE), overall and by severity (Periods 1 and 2) | Day 1 to Day 50 | |
| Number of participants who discontinue treatment due to AEs (Periods 1 and 2) | Day 1 to Day 50 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Groningen | 9728 NZ | Netherlands |
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
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.
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.
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| [14C]VH4524184 microdose | Drug | A radiolabelled microdose of [14C]VH4524184 is administered 2.5 hours after VH4524184 dose administration on Day 1 (Period1). |
|
| [14C]VH4524184 | Drug | One dose of radiolabelled [14C]VH4524184 is administered to participants at Day 15 (Period 2). |
|
| Amount of TRA excreted in vomitus (Ae vomit) (Period 2) | At Day 15 |
| Total amount of TRA excreted (Ae total) (Period 1) | 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). | From Day 1 up to Day 14 |
| Total amount of TRA excreted (Ae total) (Period 2) | 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 |
| Fraction of TRA excreted in urine (fe urine) (Period 1) | 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) | 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) | 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) | 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 |
| Fraction of TRA excreted in vomitus (fe vomit) (Period 1) | At Day 1 |
| Fraction of TRA excreted in vomitus (fe vomit) (Period 2) | At Day 15 |
| Total fraction of TRA excreted (fe total) (Period 1) | 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 |
| Total fraction of TRA excreted (fe total) (Period 2) | 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 |
| Maximum concentration (Cmax) of VH4524184 in plasma (Period 1) | Day 1 to Day 14 |
| Maximum concentration (Cmax) of VH4524184 in plasma (Period 2) | Day 15 to Day 43 |
| Maximum concentration (Cmax) of [14C]VH4524184 in plasma (Period 1) | Day 1 to Day 14 |
| Maximum concentration (Cmax) of TRA in plasma (Period 1) | Day 1 to Day 14 |
| Maximum concentration (Cmax) of TRA in plasma (Period 2) | Day 15 to Day 43 |
| Cmax of TRA in whole blood (Period 1) | Day 1 to Day 14 |
| Cmax of TRA in whole blood (Period 2) | Day 15 to Day 43 |
| Time to maximum concentration (tmax) of VH4524184 in plasma (Period 1) | Day 1 to Day 14 |
| Time to maximum concentration (tmax) of VH4524184 in plasma (Period 2) | Day 15 to Day 43 |
| Time to maximum concentration (tmax) of [14C]VH4524184 in plasma (Period 1) | Day 1 to Day 14 |
| Time to maximum concentration (tmax) of TRA in plasma (Period 1) | Day 1 to Day 14 |
| Time to maximum concentration (tmax) of TRA in plasma (Period 2) | Day 15 to Day 43 |
| Time to maximum concentration (tmax) of TRA in whole blood (Period 1) | Day 1 to Day 14 |
| Time to maximum concentration (tmax) of TRA in whole blood (Period 2) | Day 15 to Day 43 |
| Area under the concentration-time curve from time zero to the last measured timepoint (AUC 0-t) of VH4524184 in plasma (Period 1) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Day 15 to Day 43 |
| Amount of VH4524184 excreted in urine (Ae urine) (Period 2) | Day 15 to Day 43 |
| Fraction of VH4524184 excreted in urine (fe urine) (Period 2) | Day 15 to Day 43 |
| Renal clearance of VH4524184 (CL R) (Period 2) | Day 15 to Day 43 |
| Change from baseline for aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and alkaline phosphatase (Periods 1 and 2) | 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) | On Days 2, 14, 16, 28 and 42 |
| Blood to plasma ratio of TRA (Periods 1 and 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. | Day 1 to Day 14 (Period 1) and Day 15 to Day 28 (Period 2) |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |