A Multiple Dose Study to Evaluate the Safety and Efficacy of MK-2748 in Hepatitis C-Infected Participants (MK-2748-002 AM1)

Hepatitis C Clinical Trial

Official title:

A Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2748 in Hepatitis C-Infected Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593735
• Other study ID #: 2748-002
• Secondary ID: 2011-006296-18
• Status: Completed
• Phase: Phase 1
• First received: May 4, 2012
• Last updated: January 21, 2015
• Start date: May 2012
• Est. completion date: February 2013

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a multiple dose study of the safety and efficacy of MK-2748 to be done in 2 Parts. Part I will enroll genotype 1 (GT1) hepatitis C virus (HCV)-infected participants and Part II will enroll genotype 3 (GT3) HCV-infected participants. Both Parts may run concurrently or may be staggered.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria:

• Clinical diagnosis of chronic HCV infection (GT1 or GT3) for at least 6 months and detectable HCV-RNA in peripheral blood

• Body mass index (BMI) of 18 to 37 kg/m^2

• No clinically significant abnormality on electrocardiogram (ECG)

• Stable health

• Willing to use appropriate contraception throughout the study and for 90 days after last dose of study drug

Exclusion criteria:

• Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study

• History of stroke, chronic seizures, or major neurological disorder

• History of clinically significant endocrine, gastrointestinal (excepting HCV infection), cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases

• History of neoplastic disease (exceptions of adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, or other malignancies which have been successfully treated =10 years prior and unlikely to recur

• Positive Hepatitis B surface antigen

• Documented human immunodeficiency virus (HIV) infection

• Consumption of excessive amounts of alcohol, defined as greater than 2 glasses of alcoholic beverages (1 glass is approximately equivalent to: beer [284 mL/10 ounces],wine [125 mL/4 ounces], or distilled spirits [25 mL/1 ounce]) per day

• Consumption of excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) or coffee, tea, cola, or other caffeinated beverages per day

• Major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to study enrollment

• History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

• Current regular user (including "recreational use") of any illicit drugs or history of drug (including alcohol) abuse within approximately 2 months prior to enrollment

• Evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug induced hepatitis, autoimmune hepatitis

• Previous treatment with other HCV NS3/4A protease inhibitors

• Previous exposure to interferon-alpha and/or ribavirin within 3 months prior to study enrollment

• Clinical or laboratory evidence of advanced or decompensated liver disease; evidence of bridging fibrosis or higher grade fibrosis (Metavir score =3)

• Participation in another investigational study within 4 weeks prior to enrollment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• MK-2748
MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment
• Placebo
Placebo tablets, orally, once daily for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT1 HCV-infected participants		Predose on Day 1 through Day 56	No
Primary	Change from baseline in HCV RNA viral load (log 10 copies/mL) in GT3 HCV-infected participants		Predose on Day 1 through Day 56	No
Primary	Number of participants experiencing clinical or laboratory adverse events (AEs)		From first dose up to 21 days	Yes
Primary	Number of participants discontinued from study treatment due to AEs		From Day 1 through Day 7	Yes
Secondary	Area under the plasma concentration curve from Hour 0 to Hour 24 (AUC0-24hr) for MK-2748		Day 1 and Day 7, predose through 24 hours post-dose	No
Secondary	Plasma concentration of MK-2748 (C24) on Day 7 of dosing		24 hours post-dose on Day 7	No