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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT02161510
• Date of registration: 10/06/2014
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Participants With Hepatitis C (MK-2248-002)
• Scientific title: A Multiple Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MK-2248 in Subjects With Hepatitis C Infection
• Date of first enrolment: July 2014
• Target sample size: 13
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02161510
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Moldova, Republic of

Contacts

• Name: Medical Director
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis C

Intervention(s)

Drug: MK-2248

Primary Outcome(s)

Number of participants experiencing an adverse event (AE) [Time Frame: Up to Day 42]

Maximum change from baseline in VL [Time Frame: Up to Day 42]

Number of participants who discontinue from study treatment due to an AE [Time Frame: Up to Day 7]

Secondary Outcome(s)

Maximum observed post-dose plasma concentration (Cmax) of MK-2248 and circulating metabolite(s) [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]

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]

Accumulation ratio of MK-2248 and circulating metabolite(s) in plasma [Time Frame: Up to Day 10]

Apparent volume of distribution (V/F) of MK-2248 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]

Plasma concentration at 24 hours post-dose (C24hr) 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]

Secondary ID(s)

2248-002

2014-001494-14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors