A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects
A Phase Ia/Ib Study Assessing Single and Multiple Doses of CDI-31244: A Non-Nucleoside Inhibitor in Healthy and Hepatitis C Virus-Infected Subjects
  • Phase

    Phase 1
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    cdi-31244 ...
  • Study Participants

This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor (NNI) in healthy volunteers and HCV infected individuals
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.
Study Started
Apr 30
Primary Completion
Mar 31
Study Completion
Apr 30
Last Update
Apr 20

Drug CDI-31244


  • Other names: CC-31244

Drug Placebo

no active ingredients

  • Other names: CDI-31244 Placebo

Cohort 1A HV Experimental

CDI-31244 20 mg active or placebo single dose (SD)

Cohort 2A HV Experimental

CDI-31244 50 mg active or placebo SD

Cohort 3A HV Experimental

CDI-31244 100 mg active or placebo SD

Cohort 4A HV Experimental

CDI-31244 200 mg active or placebo SD; food effect

Cohort 5A HV Experimental

CDI-31244 400 mg active or placebo SD

Cohort 6A HV Experimental

CDI-31244 200 mg active or placebo multiple dose (MD)

Cohort 7A HV Experimental

CDI-31244 200 mg active or placebo MD

Cohort 8A HV Experimental

CDI-31244 400 mg active or placebo MD

Cohort 1B HCV genotype (GT) 1 Experimental

CDI-31244 400 mg active or placebo MD

Cohort 2B HCV GT 1 Experimental

CDI-31244 600 mg active or placebo MD

Cohort 3B HCV GT 1 Experimental

CDI-31244 800 mg active or placebo MD


Main Inclusion Criteria:


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 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.

Main Exclusion Criteria:


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.


Positive screen for anti-HCV antibody


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.
No Results Posted