Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)

NCT02392494 | Completed Phase 1 Results

• 3 other identifiers: 1075-0022015-000127-93MK-1075-002
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to determine the ability of MK-1075 to reduce HCV viral load, following administration of a single dose in HCV-infected participants.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Experiencing an Adverse Event (AE)

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that experienced an AE was reported for each treatment panel.

  Up to Study Day 14

• Percentage of Participants Who Discontinued Study Due to an AE

  An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that discontinued the study due to an AE was reported for each treatment panel.

  Up to Study Day 14

• Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075

  For assessment of antiviral activity of MK-1075 at each study dose, baseline and post-dose HCV ribonucleic acid (RNA) (log10) were measured at pre-dose and 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. The estimated change from baseline in HCV RNA VL (log10) was calculated for each participant by time point after each single dose, and the maximum change (reduction) in HCV RNA was determined and reported for each treatment arm using an Analysis of Variance (ANOVA) model.

  Pre-dose (baseline), 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose

Study Arms (4)

MK-1075 100 mg (Panel A)

EXPERIMENTAL

HCV-infected participants receive a single 100 mg dose of MK-1075.

Drug: MK-1075

MK-1075 200 mg (Panel B)

EXPERIMENTAL

HCV-infected participants receive a single 200 mg dose of MK-1075.

Drug: MK-1075

MK-1075 400 mg (Panel C)

EXPERIMENTAL

HCV-infected participants receive a single 400 mg dose of MK-1075.

Drug: MK-1075

MK-1075 800 mg (Panel D)

EXPERIMENTAL

HCV-infected participants receive a single 800 mg dose of MK-1075.

Drug: MK-1075

Interventions

MK-1075 DRUG

MK-1075 supplied as 10 mg or 100 mg tablets for oral administration.

MK-1075 100 mg (Panel A); MK-1075 200 mg (Panel B); MK-1075 400 mg (Panel C); MK-1075 800 mg (Panel D)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female of non-child bearing potential
• In good health other than HCV genotype (GT) 1 infection

You may not qualify if:

• Is mentally incapacitated or legally institutionalized
• Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases
• Has a history of cancer
• Is positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV)
• Has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to Screening
• Consumes \>2 alcoholic beverages a day or uses illegal drugs
• Has 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, or autoimmune hepatitis
• Has clinical or laboratory evidence of advanced or decompensated liver disease, evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In each panel (A, B, C, and D), participants will receive a single dose of MK-1075 (100, 200, 400, and 800 mg, respectively) in a fasted state. Safety and viral load (VL) data from the previous panel will be assessed before dosing the subsequent panel.

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 19, 2015
• Study Start: April 28, 2015
• Primary Completion: August 10, 2015
• Study Completion: August 10, 2015
• Last Updated: January 22, 2019
• Results First Posted: December 31, 2018

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share