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

NCT02760758 | Completed Phase 1

• 1 other identifier: CDI-31244-P1-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatitis C

Keywords

non-nucleoside inhibitor; NNI; HCV; DAA

Outcome Measures

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

  Day 1 to Day 35

Secondary Outcomes (5)

• Measure plasma levels of CDI-31244 after SD

  Day 1 to Day 6

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

  Day 1 to Day 13

• Measure plasma levels of CDI-31244 after MD

  Day 1 to Day 13

• Measure HCV viral load through the RNA quantitative test

  Day 1 to Day 35

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

  Day 1 to 35

Study Arms (11)

Cohort 1A HV

EXPERIMENTAL

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

Drug: CDI-31244; Drug: Placebo

Cohort 2A HV

EXPERIMENTAL

CDI-31244 50 mg active or placebo SD

Drug: CDI-31244; Drug: Placebo

Cohort 3A HV

EXPERIMENTAL

CDI-31244 100 mg active or placebo SD

Drug: CDI-31244; Drug: Placebo

Cohort 4A HV

EXPERIMENTAL

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

Drug: CDI-31244; Drug: Placebo

Cohort 5A HV

EXPERIMENTAL

CDI-31244 400 mg active or placebo SD

Drug: CDI-31244; Drug: Placebo

Cohort 6A HV

EXPERIMENTAL

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

Drug: CDI-31244; Drug: Placebo

Cohort 7A HV

EXPERIMENTAL

CDI-31244 200 mg active or placebo MD

Drug: CDI-31244; Drug: Placebo

Cohort 8A HV

EXPERIMENTAL

CDI-31244 400 mg active or placebo MD

Drug: CDI-31244; Drug: Placebo

Cohort 1B HCV genotype (GT) 1

EXPERIMENTAL

CDI-31244 400 mg active or placebo MD

Drug: CDI-31244; Drug: Placebo

Cohort 2B HCV GT 1

EXPERIMENTAL

CDI-31244 600 mg active or placebo MD

Drug: CDI-31244; Drug: Placebo

Cohort 3B HCV GT 1

EXPERIMENTAL

CDI-31244 800 mg active or placebo MD

Drug: CDI-31244; Drug: Placebo

Interventions

CDI-31244 DRUG

NNI

Also known as: CC-31244

Cohort 1A HV; Cohort 1B HCV genotype (GT) 1; Cohort 2A HV; Cohort 2B HCV GT 1; Cohort 3A HV; Cohort 3B HCV GT 1; Cohort 4A HV; Cohort 5A HV; Cohort 6A HV; Cohort 7A HV; Cohort 8A HV

Placebo DRUG

no active ingredients

Also known as: CDI-31244 Placebo

Cohort 1A HV; Cohort 1B HCV genotype (GT) 1; Cohort 2A HV; Cohort 2B HCV GT 1; Cohort 3A HV; Cohort 3B HCV GT 1; Cohort 4A HV; Cohort 5A HV; Cohort 6A HV; Cohort 7A HV; Cohort 8A HV

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Cocrystal Pharma, Inc.: lead

Study Sites (1)

Algorithme

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Judy Pattassery

  Cocrystal Pharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 4, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 20, 2021

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)