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A Study to Assess the Clinical Effects of Navarixin in Participants With Psoriasis (MK-7123-009)

17 gennaio 2019 aggiornato da: Merck Sharp & Dohme LLC

A Study to Assess the Clinical Effects of SCH 527123 in Psoriasis

This study was conducted: 1) to assess the clinical effect of Navarixin on the Psoriasis Activity and Severity Index (PASI), 2) to determine the effects of Navarixin on the Physician's Global Assessment (PGA), 3) to evaluate the safety and tolerability of Navarixin, and 4) to determine the multiple-dose pharmacokinetics of Navarixin.

Panoramica dello studio

Stato

Completato

Condizioni

Tipo di studio

Interventistico

Iscrizione (Effettivo)

31

Fase

  • Fase 2

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

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Body Mass Index (BMI) 19 to 34, BMI = weight (kg)/height (m^2).
  • Must have a diagnosis of psoriasis vulgaris (PASI >8) present for at least 1 year. Participants with an on-therapy PASI <=8 at Screening may be considered for inclusion. Participants must be discussed with the Sponsor prior to enrollment and the subject must have indicated that they are not satisfied with current therapy. To be included, participants must have a PASI >8 following washout of their current psoriasis therapy.
  • Target lesion selected must be located on the head, trunk, arms or legs and be at least 10 cm^2 in size. The lesion's total numerical ratings for erythema, infiltration, and desquamation must be at least 6 out of the possible 12. Severity score for desquamation must be at least 2.
  • Vital sign measurements (taken after ~3 minutes in a supine position) must be within the following ranges: oral body temperature between 35.0°C to 37.5°C; systolic blood pressure, 90 to 160 mm Hg; diastolic blood pressure, 45 to 90 mm Hg; pulse rate, 40 to 100 bpm.
  • Have stable disease (ie, off treatment PASI during Screening period and Baseline PASI should not differ by more than 40%).
  • Clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. Participants must have a neutrophil count of at least 2 x 10^9/L to be included.
  • Free of any clinically significant disease (other than psoriasis).
  • Willing to give written informed consent and able to adhere to dose and visit schedules.
  • For female participants: Negative serum pregnancy test (beta-hCG) and urine pregnancy test. Agree to use medically accepted methods of contraception during and for an appropriate pre-study period while receiving protocol specified medication, and for 1 month after stopping medication. Female participants of non-childbearing potential must be surgically sterilized or be postmenopausal.
  • Male subject must agree to use an adequate form of contraception for the duration of the study.
  • At Screening, ECG conduction intervals must be within gender specific normal range (ie, QTc for males <430 msec and females <450 msec) or if not within the normal range, the values must be considered clinically insignificant by the investigator and sponsor.

Exclusion Criteria:

  • Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding.
  • Participants who, in the opinion of the investigator, will not be able to participate optimally in the study.
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
  • History of any infectious disease within 4 weeks prior to drug administration and/or are positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
  • Immunocompromised participants.
  • Positive screen for drugs with a high potential for abuse or have a history of drug or alcohol abuse in the past 2 years.
  • History of mental instability or who have been treated for mood disorders.
  • Donated blood in the past 60 days.
  • Previous treatment with study medication.
  • Currently participating in another clinical study or have participated in a clinical study within 30 days.
  • Part of the study staff personnel or family members of the study staff personnel.
  • Demonstrated clinically significant (requiring intervention) allergic reactions or who are known to be allergic to components of local anesthetics.

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: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Navarixin
Navarixin 30 mg administered orally once daily for 28 days.
Navarixin capsules orally, once daily for 28 days.
Comparatore placebo: Placebo
Matching placebo to Navarixin administered orally once daily for 28 days.
Matching placebo capsules to Navarixin orally, once daily for 28 days.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Percent Change From Baseline in the Psoriasis and Activity Severity Index (PASI) Score at Day 29
Lasso di tempo: Baseline and Day 29
PASI score is a means to qualify the extent and severity of psoriatic lesions. The total score is calculated as the sum of the extent and severity of lesions on the head, arms, trunk, and legs and the score can range from 0 (no symptoms) to 72 (maximum symptoms).
Baseline and Day 29

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants by Physician's Assessment of Global Improvement (PGA) Score At Day 29
Lasso di tempo: Day 29
The PGA is a questionnaire that asks the treating physician to rate the participant's signs and symptoms on a scale where 0=worse, 1=unchanged, 2= slight improvement, 3= fair improvement, 4= good improvement, 5= excellent improvement, and 6=cleared, with higher scores indicating better outcomes.
Day 29
Mean Maximum Plasma Concentration (Cmax) of Navarixin at Day 28
Lasso di tempo: Day 28
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean Cmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Day 28
Mean Area Under the Plasma Concentration-Time Curve From Time 0-24 Hours (AUC [0-24]) of Navarixin at Day 28
Lasso di tempo: Day 28
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the mean AUC(0-24) at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Day 28
Mean Terminal Phase Half-life (T1/2) of Navarixin at Day 28
Lasso di tempo: Day 28
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours to determine the mean T1/2 of Navarixin following oral administration at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Day 28
Median Time to Maximum Plasma Concentration (Tmax) of Navarixin at Day 28
Lasso di tempo: Day 28
Participant blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours following oral administration of Navarixin to determine the Mean Tmax at Day 28. Blood samples were not collected from the placebo group to evaluate this endpoint.
Day 28

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

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 (Effettivo)

1 giugno 2007

Completamento primario (Effettivo)

1 ottobre 2007

Completamento dello studio (Effettivo)

1 ottobre 2007

Date di iscrizione allo studio

Primo inviato

22 maggio 2008

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2008

Primo Inserito (Stima)

26 maggio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 febbraio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 gennaio 2019

Ultimo verificato

1 gennaio 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • P04481 (Altro identificatore: Merck Protocol Number)
  • 2006-006601-83 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Dati/documenti di studio

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 .

Prove cliniche su Navarixin 10 mg

3
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