A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-04-30

Brief Summary

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This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor (NNI) in healthy volunteers and HCV infected individuals

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Detailed Description

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This is a single center, double-blind, placebo-controlled, randomized, single ascending oral dose and multiple oral dose design, incorporating fed/fasted comparisons.

The study will include two groups: Group A - single ascending dose (SAD) including a food effect cohort, and multiple dose (MD) in healthy volunteers (HV), and Group B MD in Hepatitis C Virus (HCV) infected individuals divided in two parts.

Five single-dose cohort are planned. For the five single-dose cohorts, a sentinel group of 2 subjects will be dosed at least one day prior to enrolling remaining subjects.

Six multiple-dose cohorts are planned. Three multiple dose cohorts in healthy volunteers and three cohorts in HCV-infected individuals.

The dosing of Group B will be conducted following safety and pharmacokinetic (PK) review of Group A. The dosing of Group B, Part 2 will be conducted only if Part 1 shows acceptable safety and efficacy results.

Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type DRUG

no active ingredients

Interventions

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CDI-31244

NNI

Intervention Type DRUG

Placebo

no active ingredients

Intervention Type DRUG

Other Intervention Names

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CC-31244 CDI-31244 Placebo

Eligibility Criteria

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Inclusion Criteria

HV and HCV INFECTED SUBJECTS:

* Male or female aged ≥ 18 to ≤ 65 years;
* Body mass index ≥ 18.5 to ≤ 35.0 kg/m2;
* Body weight ≥ 50 kg;
* Negative screening for alcohol and drugs of abuse;
* Normal results on 12-lead electrocardiogram (ECG);
* For females, negative result on a pregnancy test.

HCV INFECTED SUBJECTS:

* HCV treatment-naïve subjects must have not received prior direct acting agent (DAA) treatment for hepatitis C infection;
* Documented clinical history compatible with chronic hepatitis C;
* HCV Genotype 1 by HCV genotyping performed at Screening;
* Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening;
* Laboratory evidence of no cirrhosis (negative liver biopsy or fibroscan or FibroTest, F2 or lower) within one year prior to study), if these are not available, do a FibroTest at screening, which must be F2 or lower.

Exclusion Criteria

HV and HCV INFECTED SUBJECTS:

* Females who are pregnant or are lactating;
* Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV);
* Abuse of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the investigator;
* Positive screen result for drugs of abuse or alcohol on Day -1. Use of other investigational drugs within 60 days of dosing;
* Subject with intestinal malabsorption;
* Presence of out-of-range cardiac interval on the screening ECG or other clinically significant ECG abnormalities;
* Serum creatinine \> upper limit of normal (ULN);
* Any clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.

HEALTHY VOLUNTEERS:

* Positive screen for anti-HCV antibody

HCV INFECTED SUBJECTS:

* Clinical (in the opinion of the investigator) or laboratory evidence of cirrhosis;
* History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency;
* History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC;
* Active clinically significant diseases.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes