- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07636928
Mass Balance and Absolute Oral Bioavailability of [14C]VH4524184
3 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
9
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: US GSK Clinical Trials Call Center
- Numero di telefono: 877-379-3718
- Email: GSKClinicalSupportHD@gsk.com
Backup dei contatti dello studio
- Nome: EU GSK Clinical Trials Call Center
- Numero di telefono: +44 (0) 20 89904466
- Email: GSKClinicalSupportHD@gsk.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Absolute bioavailability (F oral) of VH4524184 (Period 1)
Lasso di tempo: Day 1 up to Day 14
|
Day 1 up to Day 14
|
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Amount of total radioactivity (TRA) excreted in urine (Ae urine) (Period 1)
Lasso di tempo: 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).
|
Day 1 up to Day 14
|
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Amount of TRA excreted in urine (Ae urine) (Period 2)
Lasso di tempo: 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)
Lasso di tempo: 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).
|
Day 1 up to Day 14
|
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Amount of TRA excreted in feces (Ae feces) (Period 2)
Lasso di tempo: 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)
Lasso di tempo: At Day 1
|
At Day 1
|
|
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Amount of TRA excreted in vomitus (Ae vomit) (Period 2)
Lasso di tempo: At Day 15
|
At Day 15
|
|
|
Total amount of TRA excreted (Ae total) (Period 1)
Lasso di tempo: From Day 1 up to Day 14
|
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
|
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Total amount of TRA excreted (Ae total) (Period 2)
Lasso di tempo: Day 15 up to Day 43
|
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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
|
Fraction of TRA excreted in vomitus (fe vomit) (Period 1)
Lasso di tempo: At Day 1
|
At Day 1
|
|
|
Fraction of TRA excreted in vomitus (fe vomit) (Period 2)
Lasso di tempo: At Day 15
|
At Day 15
|
|
|
Total fraction of TRA excreted (fe total) (Period 1)
Lasso di tempo: 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)
Lasso di tempo: 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
|
|
Maximum concentration (Cmax) of VH4524184 in plasma (Period 1)
Lasso di tempo: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Maximum concentration (Cmax) of VH4524184 in plasma (Period 2)
Lasso di tempo: Day 15 to Day 43
|
Day 15 to Day 43
|
|
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Maximum concentration (Cmax) of [14C]VH4524184 in plasma (Period 1)
Lasso di tempo: Day 1 to Day 14
|
Day 1 to Day 14
|
|
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Maximum concentration (Cmax) of TRA in plasma (Period 1)
Lasso di tempo: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Maximum concentration (Cmax) of TRA in plasma (Period 2)
Lasso di tempo: Day 15 to Day 43
|
Day 15 to Day 43
|
|
|
Cmax of TRA in whole blood (Period 1)
Lasso di tempo: Day 1 to Day 14
|
Day 1 to Day 14
|
|
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Cmax of TRA in whole blood (Period 2)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Day 15 to Day 43
|
Day 15 to Day 43
|
|
|
Time to maximum concentration (tmax) of [14C]VH4524184 in plasma (Period 1)
Lasso di tempo: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Time to maximum concentration (tmax) of TRA in plasma (Period 1)
Lasso di tempo: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Time to maximum concentration (tmax) of TRA in plasma (Period 2)
Lasso di tempo: Day 15 to Day 43
|
Day 15 to Day 43
|
|
|
Time to maximum concentration (tmax) of TRA in whole blood (Period 1)
Lasso di tempo: Day 1 to Day 14
|
Day 1 to Day 14
|
|
|
Time to maximum concentration (tmax) of TRA in whole blood (Period 2)
Lasso di tempo: 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 VH4524184 in plasma (Period 1)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Day 15 to Day 43
|
Day 15 to Day 43
|
|
|
Amount of VH4524184 excreted in urine (Ae urine) (Period 2)
Lasso di tempo: Day 15 to Day 43
|
Day 15 to Day 43
|
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Fraction of VH4524184 excreted in urine (fe urine) (Period 2)
Lasso di tempo: Day 15 to Day 43
|
Day 15 to Day 43
|
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Renal clearance of VH4524184 (CL R) (Period 2)
Lasso di tempo: Day 15 to Day 43
|
Day 15 to Day 43
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of participants with adverse events (AE), overall and by severity (Periods 1 and 2)
Lasso di tempo: Day 1 to Day 50
|
Day 1 to Day 50
|
|
|
Number of participants who discontinue treatment due to AEs (Periods 1 and 2)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.
|
Day 1 to Day 14 (Period 1) and Day 15 to Day 28 (Period 2)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 giugno 2026
Completamento primario (Stimato)
20 agosto 2026
Completamento dello studio (Stimato)
20 agosto 2026
Date di iscrizione allo studio
Primo inviato
29 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
3 giugno 2026
Primo Inserito (Effettivo)
9 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
9 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Infezioni a trasmissione ematica
- Malattie urogenitali
- Malattie genitali
- Malattie del sistema immunitario
- Infezioni
- Infezioni da virus a RNA
- Malattie virali
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Sindromi da deficit immunologico
- Malattie da virus lenti
- Infezioni da HIV
- Sindrome da immunodeficienza acquisita
Altri numeri di identificazione dello studio
- 223803
- 2026-525590-40 (Altro identificatore: EU CT Number)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano 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
Periodo di condivisione 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.
Criteri di accesso alla condivisione 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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
Sì
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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Center for Innovative Public Health ResearchNational Institute of Mental Health (NIMH); Makerere University; Internet Solutions...Non ancora reclutamento
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-
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