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

April 19, 2021 updated by: Cocrystal Pharma, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Algorithme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1A HV
CDI-31244 20 mg active or placebo single dose (SD)
Drug: CDI-31244
NNI
Other Names:
  • CC-31244
Drug: Placebo
no active ingredients
Other Names:
  • CDI-31244 Placebo
Experimental: Cohort 2A HV
CDI-31244 50 mg active or placebo SD
Drug: CDI-31244
NNI
Other Names:
  • CC-31244
Drug: Placebo
no active ingredients
Other Names:
  • CDI-31244 Placebo
Experimental: Cohort 3A HV
CDI-31244 100 mg active or placebo SD
Drug: CDI-31244
NNI
Other Names:
  • CC-31244
Drug: Placebo
no active ingredients
Other Names:
  • CDI-31244 Placebo
Experimental: Cohort 4A HV
CDI-31244 200 mg active or placebo SD; food effect
Drug: CDI-31244
NNI
Other Names:
  • CC-31244
Drug: Placebo
no active ingredients
Other Names:
  • CDI-31244 Placebo
Experimental: Cohort 5A HV
CDI-31244 400 mg active or placebo SD
Drug: CDI-31244
NNI
Other Names:
  • CC-31244
Drug: Placebo
no active ingredients
Other Names:
  • CDI-31244 Placebo
Experimental: Cohort 6A HV
CDI-31244 200 mg active or placebo multiple dose (MD)
Drug: CDI-31244
NNI
Other Names:
  • CC-31244
Drug: Placebo
no active ingredients
Other Names:
  • CDI-31244 Placebo
Experimental: Cohort 7A HV
CDI-31244 200 mg active or placebo MD
Drug: CDI-31244
NNI
Other Names:
  • CC-31244
Drug: Placebo
no active ingredients
Other Names:
  • CDI-31244 Placebo
Experimental: Cohort 8A HV
CDI-31244 400 mg active or placebo MD
Drug: CDI-31244
NNI
Other Names:
  • CC-31244
Drug: Placebo
no active ingredients
Other Names:
  • CDI-31244 Placebo
Experimental: Cohort 1B HCV genotype (GT) 1
CDI-31244 400 mg active or placebo MD
Drug: CDI-31244
NNI
Other Names:
  • CC-31244
Drug: Placebo
no active ingredients
Other Names:
  • CDI-31244 Placebo
Experimental: Cohort 2B HCV GT 1
CDI-31244 600 mg active or placebo MD
Drug: CDI-31244
NNI
Other Names:
  • CC-31244
Drug: Placebo
no active ingredients
Other Names:
  • CDI-31244 Placebo
Experimental: Cohort 3B HCV GT 1
CDI-31244 800 mg active or placebo MD
Drug: CDI-31244
NNI
Other Names:
  • CC-31244
Drug: Placebo
no active ingredients
Other Names:
  • CDI-31244 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of treatment emergent adverse events (AE)
Time Frame: Day 1 to Day 35
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
Day 1 to Day 35

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure plasma levels of CDI-31244 after SD
Time Frame: Day 1 to Day 6
Plasma levels of CDI-31244 in the the single dose HV cohorts
Day 1 to Day 6
Measure plasma levels of CDI-31244 after SD in fasted and fed conditions
Time Frame: Day 1 to Day 13
The effect of food on the plasma levels of CDI-31244 in the single dose HV cohorts
Day 1 to Day 13
Measure plasma levels of CDI-31244 after MD
Time Frame: Day 1 to Day 13
Plasma levels of CDI-31244 in the multiple dose HV and HCV infected cohorts
Day 1 to Day 13
Measure HCV viral load through the RNA quantitative test
Time Frame: Day 1 to Day 35
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
Day 1 to Day 35
Measure HCV mutation through genotyping at baseline and after CDI-31244 dosing
Time Frame: Day 1 to 35
The possible emergence of hepatitis C virus resistance mutation in HCV infected subjects
Day 1 to 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cocrystal Pharma, Inc.

Investigators

  • Study Director: Judy Pattassery, Cocrystal Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 1, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDI-31244-P1-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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