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CompletedNCT02760758Updated Apr 20, 2021

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

A Phase 1 interventional study of CDI-31244 and Placebo in Hepatitis C, sponsored by Cocrystal Pharma, Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-20.

Sponsored by Cocrystal Pharma, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Hepatitis C

Keywords

  • non-nucleoside inhibitor
  • NNI
  • HCV
  • DAA
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 76 is close to the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Cocrystal Pharma, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Main 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.

Main 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
76 participants (actual)

Study arms

  • Experimental
    Cohort 1A HV

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

    Drug: CDI-31244 · Drug: Placebo

  • Experimental
    Cohort 2A HV

    CDI-31244 50 mg active or placebo SD

    Drug: CDI-31244 · Drug: Placebo

  • Experimental
    Cohort 3A HV

    CDI-31244 100 mg active or placebo SD

    Drug: CDI-31244 · Drug: Placebo

  • Experimental
    Cohort 4A HV

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

    Drug: CDI-31244 · Drug: Placebo

  • Experimental
    Cohort 5A HV

    CDI-31244 400 mg active or placebo SD

    Drug: CDI-31244 · Drug: Placebo

  • Experimental
    Cohort 6A HV

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

    Drug: CDI-31244 · Drug: Placebo

  • Experimental
    Cohort 7A HV

    CDI-31244 200 mg active or placebo MD

    Drug: CDI-31244 · Drug: Placebo

  • Experimental
    Cohort 8A HV

    CDI-31244 400 mg active or placebo MD

    Drug: CDI-31244 · Drug: Placebo

  • Experimental
    Cohort 1B HCV genotype (GT) 1

    CDI-31244 400 mg active or placebo MD

    Drug: CDI-31244 · Drug: Placebo

  • Experimental
    Cohort 2B HCV GT 1

    CDI-31244 600 mg active or placebo MD

    Drug: CDI-31244 · Drug: Placebo

  • Experimental
    Cohort 3B HCV GT 1

    CDI-31244 800 mg active or placebo MD

    Drug: CDI-31244 · Drug: Placebo

Interventions

  • DrugCDI-31244

    NNI

    Also known as: CC-31244

  • DrugPlacebo

    no active ingredients

    Also known as: CDI-31244 Placebo

06

What researchers measure

Primary outcomes

  1. Number of treatment emergent adverse events (AE)

    The safety and the tolerability of single and multiple oral doses of CDI-31244 through number of AEs observed in HV and HCV infected subjects

    Time frame: Day 1 to Day 35

Secondary outcomes

  1. Measure plasma levels of CDI-31244 after SD

    Plasma levels of CDI-31244 in the the single dose HV cohorts

    Time frame: Day 1 to Day 6

  2. Measure plasma levels of CDI-31244 after SD in fasted and fed conditions

    The effect of food on the plasma levels of CDI-31244 in the single dose HV cohorts

    Time frame: Day 1 to Day 13

  3. Measure plasma levels of CDI-31244 after MD

    Plasma levels of CDI-31244 in the multiple dose HV and HCV infected cohorts

    Time frame: Day 1 to Day 13

  4. Measure HCV viral load through the RNA quantitative test

    The clinical efficacy of CDI-31244 in HCV-infected subjects as measured by the maximal change in antiviral activity through changes in the HCV RNA load

    Time frame: Day 1 to Day 35

  5. Measure HCV mutation through genotyping at baseline and after CDI-31244 dosing

    The possible emergence of hepatitis C virus resistance mutation in HCV infected subjects

    Time frame: Day 1 to 35

07

Study locations

1 site
  • Algorithme
    Montreal, Quebec, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02760758
Lead sponsor
Cocrystal Pharma, Inc.
Responsible party
Sponsor
First posted
May 4, 2016
Start date
Apr 2016
Primary completion
Mar 2017
Completion
Apr 2017
Last update
Apr 20, 2021

Study contacts

Judy Pattassery
study director · Cocrystal Pharma, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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