Study Assessing Single and Multiple Doses of IDX21459 in Healthy and HCV-Infected Subjects

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: Matching Placebo; Drug: IDX21459

Study type: Interventional

Funder types: Industry

Identifiers

NCT02112942

7822-001

IDX-04C-001

Details and patient eligibility

About

A multi-part study to evaluate the safety and PK of single ascending doses of IDX21549 in healthy and HCV-infected subjects. The effect of food on the PK of IDX21549 will also be evaluated. Antiviral activity will also be assessed in HCV-infected subjects.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All subjects

• Subjects are in good general health.
• Subjects have provided written informed consent form.
• All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug. HCV Subjects
• Documented clinical history compatible with chronic hepatitis C without cirrhosis.
• Treatment-naïve
• HCV Genotype 1

Exclusion criteria

All subjects

• Pregnant or breastfeeding
• Co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).
• Decompensated liver disease
• Other clinically significant medical conditions or laboratory abnormalities.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 3 patient groups

Group A

Experimental group

Description:

Healthy subjects, sequential dose escalation, IDX21459 capsules or Matching Placebo capsules, once daily, up to 7 days

Treatment:

Drug: IDX21459

Drug: Matching Placebo

Group B

Experimental group

Description:

HCV subjects genotype 1, IDX21459 capsules, once for 1 day

Treatment:

Drug: IDX21459

Group C

Experimental group

Description:

HCV subjects genotype 1, IDX21459 capsules or Matching Placebo capsules, once daily, for 7 days

Treatment:

Drug: IDX21459

Drug: Matching Placebo