- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02161510
Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)
5 juni 2015 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
13
Fas
- Fas 1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Part I: MK-2248 200 mg (Panel A)
HCV participants will take MK-2248 200 mg by mouth once daily for 7 days.
|
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
|
Experimentell: 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.
|
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
|
Experimentell: 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.
|
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
|
Experimentell: 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.
|
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
|
Experimentell: Part II: MK-2248 200 mg (Panel E)
HCV participants will take MK-2248 200 mg by mouth once daily for 7 days.
|
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
|
Experimentell: 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.
|
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
|
Experimentell: 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.
|
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
|
Experimentell: 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.
|
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
|
Experimentell: 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.
|
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
|
Experimentell: 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.
|
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Maximum change from baseline in VL
Tidsram: Up to Day 42
|
Up to Day 42
|
Number of participants experiencing an adverse event (AE)
Tidsram: Up to Day 42
|
Up to Day 42
|
Number of participants who discontinue from study treatment due to an AE
Tidsram: Up to Day 7
|
Up to Day 7
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Plasma concentration at 24 hours post-dose (C24hr) of MK-2248 and circulating metabolite(s)
Tidsram: 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)
Tidsram: Up to Day 10
|
Up to Day 10
|
Maximum observed post-dose plasma concentration (Cmax) of MK-2248 and circulating metabolite(s)
Tidsram: 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
Tidsram: 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
Tidsram: Up to Day 10
|
Up to Day 10
|
Accumulation ratio of MK-2248 and circulating metabolite(s) in plasma
Tidsram: 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
Tidsram: Up to Day 10
|
Up to Day 10
|
Apparent volume of distribution (V/F) of MK-2248 in plasma
Tidsram: Up to Day 10
|
Up to Day 10
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2014
Primärt slutförande (Faktisk)
1 november 2014
Avslutad studie (Faktisk)
1 april 2015
Studieregistreringsdatum
Först inskickad
10 juni 2014
Först inskickad som uppfyllde QC-kriterierna
10 juni 2014
Första postat (Uppskatta)
11 juni 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
8 juni 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 juni 2015
Senast verifierad
1 juni 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2248-002
- 2014-001494-14 (EudraCT-nummer)
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