Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Vurdering af HPHC-eksponering hos rygere, der skifter til THS/TP18 med forskellige enhedsvariationer

5. november 2026 opdateret af: Philip Morris Products S.A.

Et randomiseret, kontrolleret, åbent, 6 parallelle arme studie til vurdering af eksponering for udvalgte skadelige og potentielt skadelige bestanddele (HPHC) i cigaretrøg hos voksne rygere, der skifter til tobaksopvarmningssystemer (THS/TP18) med forskellige enhedsvariationer sammenlignet med fortsat cigaretrøgning

This is a randomized, controlled, open-label, 6 parallel arms study to assess reduced exposure of biomarkers of exposure (BoE) of selected HPHC in smokers switching to TP18 (a prototype heated tobacco device) or THS relative to smokers who continue smoking CIG after 5 days of confinement period, followed by 2 days of pharmacokinetic (PK) period of single use of THS/TP18 and CIG, and followed by an ambulatory period.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Aktiv, ikke rekrutterende

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

This randomized, controlled, open-label study comprises six parallel arms and is designed to evaluate reductions in biomarkers of exposure (BoE) to selected HPHCs in adult smokers switching toTP18 (a prototype heated tobacco device with four variants: THS1, THS2, THS3, THS4) or THS5 relative to smokers who continue smoking CIG after 5 days of confinement period followed by 2 days of pharmacokinetic (PK) period of single use of THS/TP18 and CIG, and followed by an ambulatory period.

During the 5-day confinement period, participants will be randomized to use only their assigned product and will operate their assigned devices (THS1, THS2, THS3, THS4, or THS5) with their corresponding sticks or continue smoking CIG ad libitum (6 arms in total).

In the subsequent 2-day PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. Participants randomized to the CIG arm at Baseline will not participate in this period.

During the ambulatory period, participants randomized to one of the TP18 versions at Baseline will be free to choose and use any TP18 variant at any time, ad libitum. Participants randomized at Baseline to TP18 will continue using THS ad libitum. Participants randomized to the CIG arm will only be smoking cigarettes, ad libitum.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
108

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

21 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participant has signed the ICF and understands the information provided in it.
  • Participant is male or female and between 21 and 65 years old (inclusive).
  • Participant has been a smoker for at least 2 years prior to the screening visit and is willing to switch to THS and TP18.
  • Participant has smoked on average ≥10 commercially available CIGs/day over the last 30 days. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL).
  • Participant does not plan to quit smoking within the next three months.
  • Participant is available for the entire study period and willing to comply with the study procedures, including product use assignments and periods of abstinence from any nicotine/tobacco-containing products, and willing to adhere to a standardized diet (during confinement period and during overnight stays on Day 30 and Day 60).

Exclusion Criteria:

  • As per the Investigator's judgment, the participant cannot participate in the study for any reason other than medical (e.g., psychological, social reason).
  • Participant is legally incompetent, or physically or mentally incapable of giving consent (e.g., in emergency situations, under guardianship, prisoners).
  • Participant has a health condition which requires medication or any other clinically relevant finding based on available assessments from the Screening period (e.g., safety panel, pulmonary function test, vital signs, physical examination, ECG, and medical history), as determined by the Principal Investigator or designee.
  • Participant experienced within 30 days prior to screening/admission a body temperature >37.9°C or an acute illness (e.g., upper respiratory-tract infection, viral infection, etc.).
  • According to the Investigator's judgment, the participant has medical conditions that require or will require medical intervention (e.g., initiation of treatment, surgery, hospitalization) during the study period, which may interfere with study participation and/or study results.
  • Participant uses medication that aids in smoking cessation.
  • Participant experiences difficulty with venipuncture and/or poor venous access.
  • Participant has a hemoglobin level < 11.0 g/dL for females and < 12.0 g/dL for males at the Screening visit.
  • Participant has a positive nitrite urinary test at screening or on admission day (Day -2)
  • Participant has donated blood or received whole blood or blood products within the past 3 months.
  • BMI < 18.5 kg/m2 or ≥ 32.0 kg/m2.
  • Positive serology test for HIV 1/2, HBV, or HCVa.
  • Participant has a positive alcohol breath test and/or has a history of alcohol disorder that could interfere with their participation in the study.
  • The participant has a positive urine drug test.
  • Participant or one of their family members is a current or former employee of the tobacco industry, manufacturing or distributing e-cigarettes or other nicotine/tobacco-containing products.
  • A participant or a family member is an employee of the investigational site or of any other parties involved in the study.
  • Participant has participated in another clinical study within 30 days or within a period equivalent to five half-lives of the investigational product from that study, whichever is longer. .
  • Participant has been previously screened or enrolled in this study (unless they are alternate subjects).
  • Female participant is pregnant (does not have negative pregnancy tests at screening and/or at admission) or is breastfeeding.
  • For women of childbearing potential only and males: participant does not agree to use an acceptable method of effective contraception.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Andet: THS1

During the confinement period, participants will use only their assigned product THS 1 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum.
Andet: THS1 (TP18 variant 1)

TP18 prototype variant "1" (THS1) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.
Andet: THS2

During the confinement period, participants will use only their assigned product THS 2 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum.
Andet: THS2 (TP18 variant 2)

TP18 prototype variant "2" (THS2) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.
Andet: THS3

During the confinement period, participants will use only their assigned product THS 3 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum.
Andet: THS3 (TP18 variant 3)

TP18 prototype variant "3" (THS3) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.
Andet: THS4

During the confinement period, participants will use only their assigned product THS 4 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they may choose any variant (THS1, THS2, THS3, or THS4) at any time, ad libitum.
Andet: THS4 (TP18 variant 4)

TP18 prototype variant "4" (THS4) and associated tobacco sticks. The Sponsor will supply two types of sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants can choose either or both variants.
Andet: THS5

During the confinement period, participants will use only their assigned product THS 5 (with the corresponding sticks) ad libitum. During the PK period, they will complete a four-way single-product crossover using THS/TP18 and CIG, according to randomized product sequences. During the ambulatory period, they will be continue to use THS5 ad libitum.
Andet: THS5 (THS 3.0 reference device)

THS 3.0 device (reference) and the corresponding tobacco sticks will be provided by the Sponsor. There are two variants of the sticks: regular (tobacco flavor) and non-characterizing menthol flavor. Participants may choose either variant or both.
Andet: CIG

During the confinement period, participants will use only their usual brand of commercially available CIG ad libitum.

This arm will not participate in the PK period and will move directly to the ambulatory period. During the ambulatory period, participants will smoke only cigarettes, ad libitum.
Andet: CIG (Cigarette)

Current cigarette smokers will use their usual brand of commercially available CIG.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
3-hydroxypropyl mercapturic acid (3-HPMA) in Urine (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Concentrations of 3-HPMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured from Day -1 to Day 5.
2-cyanoethyl mercapturic acid N-acetyl-S-(2-cyanoethyl)-L-cysteine (2-CyEMA) in Urine (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Concentrations of 2-CyEMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured from Day -1 to Day 5.
Monohydroxybutenyl mercapturic acid (MHBMA) in Urine (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Concentrations of MHBMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured from Day -1 to Day 5.
Total N-nitrosonornicotine (total NNN) in Urine (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Concentrations of total NNN measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured from Day -1 to Day 5.
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in Urine (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Concentrations of total NNAL measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured from Day -1 to Day 5.
Carboxyhemoglobin (COHb) in Blood (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Carboxyhemoglobin (COHb) is assayed from whole blood and expressed as percentage of the total hemoglobin saturated with carbon monoxide.
Measured from Day -1 to Day 5.

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
S-phenylmercapturic acid (S-PMA) in Urine (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Concentrations of S-PMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured from Day -1 to Day 5.
2-hydroxyethylmercapturic acid (2-HEMA) in Urine (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Concentrations of 2-HEMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured from Day -1 to Day 5.
3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) in Urine (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Concentrations of 3-HMPMA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured from Day -1 to Day 5.
Total 3-hydroxybenzo(a)pyrene (3-OH-B[a]P) in Urine (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Concentrations of 3-OH-B[a]P measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured from Day -1 to Day 5.
4-aminobiphenyl (4-ABP) in Urine (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Concentrations of 4-ABP measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured from Day -1 to Day 5.
2-aminonaphtalene (2-NA) in Urine (confinement period)
Tidsramme: Measured from Day -1 to Day 5.

Concentrations of 2-NA measured in 24-hour urine and expressed as concentration adjusted for creatinine.
Measured from Day -1 to Day 5.

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma nicotine concentrations [C0h] to [C6h] (pharmacokinetic period)
Tidsramme: Measured from Day 6 to Day 7.

To measure the background-corrected plasma nicotine concentrations (C0h) to (C12h)
Measured from Day 6 to Day 7.
Maximum plasma nicotine concentration [Cmax] (pharmacokinetic period)
Tidsramme: Measured from Day 6 to Day 7.

To measure the background-corrected maximum plasma nicotine concentration [Cmax]
Measured from Day 6 to Day 7.
Area under the plasma nicotine concentration-time curve (pharmacokinetic period)
Tidsramme: Measured from Day 6 to Day 7.

To measure the area under the background-corrected plasma nicotine concentration-time curve (AUC) from the start of product use (T0) to the timepoint of last quantifiable concentration [AUC0-last] and extrapolated to infinity [AUC0-infinity]
Measured from Day 6 to Day 7.
Maximum concentration [Tmax] (pharmacokinetic period)
Tidsramme: Measured from Day 6 to Day 7.

To measure the time to the background-corrected maximum concentration [Tmax]
Measured from Day 6 to Day 7.
3-hydroxypropyl mercapturic acid (3-HPMA) in Urine (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Concentrations of 3-HPMA measured in spot urine and expressed as concentration adjusted for creatinine.
Measured on Day 30 and Day 60.
2-cyanoethyl mercapturic acid N-acetyl-S-(2- cyanoethyl)-L-cysteine (2-CyEMA) in Urine (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Concentrations of 2-CyEMA measured in spot urine and expressed as concentration adjusted for creatinine.
Measured on Day 30 and Day 60.
Monohydroxybutenyl mercapturic acid (MHBMA) in Urine (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Concentrations of MHBMA measured in spot urine and expressed as concentration adjusted for creatinine.
Measured on Day 30 and Day 60.
Total N-nitrosonornicotine (total NNN) in Urine (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Concentrations of total NNN measured in spot urine and expressed as concentration adjusted for creatinine.
Measured on Day 30 and Day 60.
Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Concentrations of total NNAL measured in spot urine and expressed as concentration adjusted for creatinine.
Measured on Day 30 and Day 60.
Carboxyhemoglobin (COHb) in Blood (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Carboxyhemoglobin (COHb) is assayed from whole blood and expressed as percentage of the total hemoglobin saturated with carbon monoxide.
Measured on Day 30 and Day 60.
S-phenylmercapturic acid (S-PMA) in Urine (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Concentrations of S-PMA measured in spot urine and expressed as concentration adjusted for creatinine.
Measured on Day 30 and Day 60.
2-hydroxyethylmercapturic acid (2-HEMA) in Urine (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Concentrations of 2-HEMA measured in spot urine and expressed as concentration adjusted for creatinine.
Measured on Day 30 and Day 60.
3-hydroxy-1-methylpropylmercapturic acid (3-HMPMA) in Urine (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Concentrations of 3-HMPMA measured in spot urine and expressed as concentration adjusted for creatinine.
Measured on Day 30 and Day 60.
Total 3-hydroxybenzo(a)pyrene (3-OH-B[a]P) in Urine (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Concentrations of 3-OH-B[a]P measured in spot urine and expressed as concentration adjusted for creatinine.
Measured on Day 30 and Day 60.
4-aminobiphenyl (4-ABP) in Urine (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Concentrations of 4-ABP measured in spot urine and expressed as concentration adjusted for creatinine.
Measured on Day 30 and Day 60.
2-aminonaphtalene (2-NA) in Urine (ambulatory period)
Tidsramme: Measured on Day 30 and Day 60.

Concentrations of 2-NA measured in spot urine and expressed as concentration adjusted for creatinine.
Measured on Day 30 and Day 60.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Philip Morris Products S.A.

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Studiestol: Christelle Haziza, PhD, Philip Morris Products S.A.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
19. februar 2026

Primær færdiggørelse (Faktiske)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
29. juli 2026

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
18. december 2026

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
25. februar 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
25. februar 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
2. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
5. november 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • P1-REX_PK-22

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Cookieindstillinger

Vi bruger cookies for at sikre, at vi giver dig den bedste oplevelse på vores hjemmeside. For flere detaljer skal du læse omhyggeligt vores Politik om beskyttelse af personlige oplysninger og cookies. ...>>>Du kan når som helst ændre dine præferencer eller trække dit samtykke tilbage ved at slette cookies fra din hjemmeside eller computer som beskrevet i politikken. Accepter det og vælg dine præferencer ved at markere de tilsvarende felter i afsnittet "Administrer indstillinger" nedenfor. Læs vores servicevilkår omhyggeligt, inden du fortsætter med at bruge nogen del af dette websted.
«Administrer indstillinger