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Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)

5. juni 2015 opdateret af: Merck Sharp & Dohme LLC

A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Subjects With Hepatitis C Infection

The objective of this study is to identify a safe dose of MK-2248 in participants with Hepatitis C Virus (HCV) that mediates at least a 3 log10 reduction in viral load (VL) from baseline. It is anticipated that once-daily administration of a safe and well tolerated dose of MK-2248 will reduce VL by at least 3 log10 IU/mL.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In this Phase 1b study, the pharmacokinetic (PK), pharmacodynamic (PD), and safety profile of MK-2248 in HCV-infected participants will be evaluated as follows: Part I will assess sequentially ascending MK-2248 doses from 200 mg to ≤800 mg over 4 panels (A, B, C, and D). Part II will assess sequentially ascending MK-2248 doses from 200 mg to ≤800 mg over 4 panels (E, F, G, and H). Part III will assess sequentially ascending MK-2248 doses ranging up to ≤800 mg in 2 panels (I and J). The potential relationship between plasma MK-2248 levels and VL reduction will be determined.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

13

Fase

  • Fase 1

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

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • clinical diagnosis of chronic HCV defined by positive serology for HCV or positive HCV RNA for at least 6 months and detectable HCV RNA in peripheral blood ≥10^5 IU/mL at screening
  • Body Mass Index (BMI) ≥18 to <37 kg/m^2
  • in good health other than HCV infection with normal laboratory values

Exclusion Criteria:

  • history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary, or major neurological abnormalities or disease
  • history of cancer other than adequately treated non-melanomatous skin carcinoma, malignancies which have been successfully treated ≥10 years prior with no recurrence, or cancer that is unlikely to sustain a recurrence for the duration of the trial
  • history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
  • positive for hepatitis B surface antigen or human immunodeficiency virus
  • had major surgery or lost 1 unit of blood within 4 weeks prior to screening
  • QTc interval ≥470 msec (males) or ≥480 msec (females)
  • received prior treatment with other HCV inhibitors
  • clinical or laboratory evidence of decompensated liver disease

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part I: MK-2248 200 mg (Panel A)
HCV participants will take MK-2248 200 mg by mouth once daily for 7 days.
Medicin: MK-2248
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
Eksperimentel: Part I: MK-2248 ≤800 mg (Panel B)
Based on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Medicin: MK-2248
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
Eksperimentel: Part I: MK-2248 ≤800 mg (Panel C)
Based on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth for 7 days.
Medicin: MK-2248
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
Eksperimentel: Part I: MK-2248 ≤800 mg (Panel D)
Based on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Medicin: MK-2248
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
Eksperimentel: Part II: MK-2248 200 mg (Panel E)
HCV participants will take MK-2248 200 mg by mouth once daily for 7 days.
Medicin: MK-2248
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
Eksperimentel: Part II: MK-2248 ≤800 mg (Panel F)
Based on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Medicin: MK-2248
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
Eksperimentel: Part II: MK-2248 ≤800 mg (Panel G)
Based on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Medicin: MK-2248
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
Eksperimentel: Part II: MK-2248 ≤800 mg (Panel H)
Based on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Medicin: MK-2248
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
Eksperimentel: Part III: MK-2248 ≤800 mg (Panel I)
Based on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Medicin: MK-2248
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
Eksperimentel: Part III: MK-2248 ≤800 mg (Panel J)
Based on safety, PK, and PD data from the preceding panel, HCV participants will take MK-2248 at approximately ≤800 mg by mouth once daily for 7 days.
Medicin: MK-2248
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Maximum change from baseline in VL
Tidsramme: Up to Day 42
Up to Day 42
Number of participants experiencing an adverse event (AE)
Tidsramme: Up to Day 42
Up to Day 42
Number of participants who discontinue from study treatment due to an AE
Tidsramme: Up to Day 7
Up to Day 7

Sekundære resultatmål

Resultatmål
Tidsramme
Plasma concentration at 24 hours post-dose (C24hr) of MK-2248 and circulating metabolite(s)
Tidsramme: Up to Day 10
Up to Day 10
Area under the plasma-concentration curve at zero to 24 hours post-dose (AUC[0-24hr]) of MK-2248 and circulating metabolite(s)
Tidsramme: Up to Day 10
Up to Day 10
Maximum observed post-dose plasma concentration (Cmax) of MK-2248 and circulating metabolite(s)
Tidsramme: Up to Day 10
Up to Day 10
Time post-dose at which the maximum observed plasma concentraton (Tmax) of MK-2248 and circulating metabolite(s) occurs
Tidsramme: Up to Day 10
Up to Day 10
Time required for Cmax to decrease by half (apparent t1/2) of MK-2248 and circulating metabolite(s) in plasma
Tidsramme: Up to Day 10
Up to Day 10
Accumulation ratio of MK-2248 and circulating metabolite(s) in plasma
Tidsramme: Up to Day 10
Up to Day 10
Total clearance (amount of drug cleared relative to the total systemically available amount per unit time [CL/F]) of MK-2248 in plasma
Tidsramme: Up to Day 10
Up to Day 10
Apparent volume of distribution (V/F) of MK-2248 in plasma
Tidsramme: Up to Day 10
Up to Day 10

Samarbejdspartnere og efterforskere

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

Sponsor

Merck Sharp & Dohme LLC

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

1. juli 2014

Primær færdiggørelse (Faktiske)

1. november 2014

Studieafslutning (Faktiske)

1. april 2015

Datoer for studieregistrering

Først indsendt

10. juni 2014

Først indsendt, der opfyldte QC-kriterier

10. juni 2014

Først opslået (Skøn)

11. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2015

Sidst verificeret

1. juni 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2248-002
  • 2014-001494-14 (EudraCT nummer)

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 .

Kliniske forsøg med Hepatitis C

Kliniske forsøg med MK-2248

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Trinidad & Tobago

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner