Primary:* To evaluate safety and tolerability.* To evaluate antiviral activity.Secondary:* To evaluate plasma and urine PK.* To evaluate the effect of food on the PK of the study drug.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Antiviral Activity; Parameters:
* Change in plasma HCV RNA
* Emergence of resistance mutations
Pharmacokinetic; Parameters:
* Concentrations of IDX320 in plasma and urine
Safety; Parameters:
* Adverse events, physical examination, vital signs, 12-lead ECG and standard
safety laboratory tests
Secondary outcome
Not applicable
Background summary
Hepatitis C virus (HCV) infection is a global public health problem. The global
prevalence of
hepatitis C infection is estimated at 3%, resulting in approximately 180
million HCV-infected
people worldwide. Approximately 70% of acute HCV infections become chronic
infections,
which are associated with a substantial long-term risk for progressive liver
disease and
potentially fatal long-term complications. It has been estimated that 20-50% of
patients with
chronic HCV infection are at risk for developing such long-term complications
as cirrhosis
and hepatocellular carcinoma (HCC). Up to 76% of liver cancers worldwide and
two thirds of
liver transplants in developed countries are attributed to chronic HCV
infection.
Study objective
Primary:
* To evaluate safety and tolerability.
* To evaluate antiviral activity.
Secondary:
* To evaluate plasma and urine PK.
* To evaluate the effect of food on the PK of the study drug.
Study design
Part A: a randomized, double blind, placebo-controlled, sequential dose
escalation study, with six cohorts of eight healthy male subjects each,
receiving a single oral dose of the study drug or placebo once.
Part B: not randomized, open label study, with one cohort of two HCV-infected
patients (either treatment-naive or treatment experienced, male or female),
receiving a single oral dose of the study drug once.
Intervention
Part A (healthy subjects)
Group 1: a single oral dose of 50 mg study drug or placebo on Day 1 in the fed
state.
Group 2: a single oral dose of 100 mg study drug or placebo on Day 1 in the fed
state.
Group 3: a single oral dose of 200 mg study drug or placebo on Day 1 in the fed
state.
Group 4: a single oral dose of 400 mg study drug or placebo on Day 1 in the fed
state.
Group 5: a single oral dose of eight 50 mg tablets study drug or placebo on Day
1 in the fasted state.
Group 6: an oral dose of eight 50 mg tablets study drug or placebo on Day 1, 2
and 3 in the fed state.
Part B (HCV patients)
Group 7: a single oral dose of 200 mg study drug on Day 1 in the fed state.
Study burden and risks
Procedures: pain, light bleeding, haematoma, possible an infection. Other AEs
related to the study drug are not known.
60 Hampshire street
Cambridge, MA 02139
USA
60 Hampshire street
Cambridge, MA 02139
USA
Listed location countries
Age
Inclusion criteria
1. 18-65 years of age, inclusive (or the legal age of consent per local regulations).
2.Body Mass Index (BMI) 18-35 kg/m2
3.Male subjects must have agreed to use a consistent form of an acceptable double-barrier method of birth control from first dose through at least 90 days after the last dose of the study drug.
4.Subject must have agreed not to donate sperm from the first dose through 90 days after the last dose of study drug.
5.Agrees not to consume grapefruit juice within 48 hours of reporting to the clinic on Day -1 through the end of the study.
6.Pulse * 40 BPM, systolic blood pressure * 95 mmHg and QTcF interval * 450 ms at screening and Day -1.
7. Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements.
8.Subject has provided written informed consent to participate in the study.
Exclusion criteria
1.Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-018079-15-NL |
| CCMO | NL31118.056.10 |