Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)

Hepatitis C, Chronic Clinical Trial

Official title:

A Phase I/IIa Study Assessing Single and Multiple Doses of HCV NS5A Inhibitor IDX719 in Healthy and HCV-Infected Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508156
• Other study ID #: 1894-001
• Secondary ID: IDX-06A-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 9, 2012
• Last updated: April 24, 2015
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: April 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

The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• All Participants

• Is in good general health.

• Agrees to use double-barrier method of birth control for at least 90 days after the last dose of study drugs.

• HCV Participants

• Has documented GT1, GT2, or GT3 chronic HCV infection.

Exclusion Criteria:

• All Participants

• Is pregnant or breastfeeding.

HCV Participants

• Has received prior HCV treatment.

• Is co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• IDX719
IDX719 liquid suspension (1 - 100 mg) taken by mouth.
• Placebo
Placebo liquid suspension matching IDX719 taken by mouth.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Vince B, Hill JM, Lawitz EJ, O'Riordan W, Webster LR, Gruener DM, Mofsen RS, Murillo A, Donovan E, Chen J, McCarville JF, Sullivan-Bólyai JZ, Mayers D, Zhou XJ. A randomized, double-blind, multiple-dose study of the pan-genotypic NS5A inhibitor samatasvir — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants experiencing an adverse event (AE)		Up to 14 days	Yes
Primary	Percentage of participants experiencing serious AEs (SAEs)		Up to 14 days	Yes
Primary	Change in HCV ribonucleic acid (RNA)		Baseline and Day 10	No
Primary	Maximum plasma drug concentration (Cmax)		Pre-dose Day 1 to Day 13	No
Primary	Time to maximum plasma drug concentration (Tmax)		Pre-dose Day 1 to Day 13	No
Primary	Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t)		Pre-dose Day 1 to Day 13	No
Primary	AUC from time zero to time 24 hours (AUC0-24h)		Pre-dose Day 1 to Day 1	No
Primary	AUC from time zero to time infinity (AUC0-~)		Pre-dose Day 1 to Day 13	No
Primary	Pre-dose trough plasma drug concentration (Ctrough)		Pre-dose Day 1	No
Primary	Observed terminal plasma drug concentration half-life (t1/2)		Pre-dose Day 1 to Day 13	No
Primary	Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-~ (single dose) or Dose/AUC0-t (multiple doses)		Pre-dose Day 1 to Day 13	No
Primary	Apparent oral total volume of distribution (Vz/F)		Pre-dose Day 1 to Day 13	No
Primary	Amount excreted in urine in each collection interval (Au)		Pre-dose Day 1 to Day 14	No
Primary	Cumulative urine excretion (Au0-t)		Pre-dose Day 1 to Day 14	No
Primary	Percentage of dose excreted in urine (% Dose excr)		Pre-dose Day 1 to Day 14	No
Primary	Renal clearance (CLr)		Pre-dose Day 1 to Day 14	No
Primary	Percentage of participants experiencing dose-limiting toxicity		Up to 8 days	Yes
Primary	Percentage of participants experiencing graded laboratory abnormalities		Up to 14 days	Yes