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Trial record 1 of 1 for:    CC-31244
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A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects

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ClinicalTrials.gov Identifier: NCT02760758
Recruitment Status : Completed
First Posted : May 4, 2016
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Cocrystal Pharma, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: CDI-31244 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1A HV
CDI-31244 20 mg active or placebo single dose (SD)
Drug: CDI-31244
NNI
Other Name: CC-31244

Drug: Placebo
no active ingredients
Other Name: CDI-31244 Placebo

Experimental: Cohort 2A HV
CDI-31244 50 mg active or placebo SD
Drug: CDI-31244
NNI
Other Name: CC-31244

Drug: Placebo
no active ingredients
Other Name: CDI-31244 Placebo

Experimental: Cohort 3A HV
CDI-31244 100 mg active or placebo SD
Drug: CDI-31244
NNI
Other Name: CC-31244

Drug: Placebo
no active ingredients
Other Name: CDI-31244 Placebo

Experimental: Cohort 4A HV
CDI-31244 200 mg active or placebo SD; food effect
Drug: CDI-31244
NNI
Other Name: CC-31244

Drug: Placebo
no active ingredients
Other Name: CDI-31244 Placebo

Experimental: Cohort 5A HV
CDI-31244 400 mg active or placebo SD
Drug: CDI-31244
NNI
Other Name: CC-31244

Drug: Placebo
no active ingredients
Other Name: CDI-31244 Placebo

Experimental: Cohort 6A HV
CDI-31244 200 mg active or placebo multiple dose (MD)
Drug: CDI-31244
NNI
Other Name: CC-31244

Drug: Placebo
no active ingredients
Other Name: CDI-31244 Placebo

Experimental: Cohort 7A HV
CDI-31244 200 mg active or placebo MD
Drug: CDI-31244
NNI
Other Name: CC-31244

Drug: Placebo
no active ingredients
Other Name: CDI-31244 Placebo

Experimental: Cohort 8A HV
CDI-31244 400 mg active or placebo MD
Drug: CDI-31244
NNI
Other Name: CC-31244

Drug: Placebo
no active ingredients
Other Name: CDI-31244 Placebo

Experimental: Cohort 1B HCV genotype (GT) 1
CDI-31244 400 mg active or placebo MD
Drug: CDI-31244
NNI
Other Name: CC-31244

Drug: Placebo
no active ingredients
Other Name: CDI-31244 Placebo

Experimental: Cohort 2B HCV GT 1
CDI-31244 600 mg active or placebo MD
Drug: CDI-31244
NNI
Other Name: CC-31244

Drug: Placebo
no active ingredients
Other Name: CDI-31244 Placebo

Experimental: Cohort 3B HCV GT 1
CDI-31244 800 mg active or placebo MD
Drug: CDI-31244
NNI
Other Name: CC-31244

Drug: Placebo
no active ingredients
Other Name: CDI-31244 Placebo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760758


Locations
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Canada, Quebec
Algorithme
Montreal, Quebec, Canada
Sponsors and Collaborators
Cocrystal Pharma, Inc.
Investigators
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Study Director: Judy Pattassery Cocrystal Pharma, Inc.
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Responsible Party: Cocrystal Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02760758    
Other Study ID Numbers: CDI-31244-P1-001
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cocrystal Pharma, Inc.:
non-nucleoside inhibitor
NNI
HCV
DAA
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections