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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
Maximum change from baseline in VL
Time frame: Up to Day 42
Number of participants experiencing an adverse event (AE)
Time frame: Up to Day 42
Number of participants who discontinue from study treatment due to an AE
Time frame: Up to Day 7
Plasma concentration at 24 hours post-dose (C24hr) of MK-2248 and circulating metabolite(s)
Time frame: 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)
Time frame: Up to Day 10
Maximum observed post-dose plasma concentration (Cmax) of MK-2248 and circulating metabolite(s)
Time frame: Up to Day 10
Time post-dose at which the maximum observed plasma concentraton (Tmax) of MK-2248 and circulating metabolite(s) occurs
Time frame: Up to Day 10
Time required for Cmax to decrease by half (apparent t1/2) of MK-2248 and circulating metabolite(s) in plasma
Time frame: Up to Day 10
Accumulation ratio of MK-2248 and circulating metabolite(s) in plasma
Time frame: 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
Time frame: Up to Day 10
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Apparent volume of distribution (V/F) of MK-2248 in plasma
Time frame: Up to Day 10