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A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT02760758•Cocrystal Pharma, Inc.

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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;
+3 more criteria

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:
+6 more criteria

Locations (1)

Algorithme

Montreal, Quebec, Canada

Key Dates

Start Date

April 1, 2016

Primary Completion Date

March 1, 2017

Completion Date

April 1, 2017

Last Updated

April 20, 2021

Enrollment

ACTUAL participants

Conditions

Hepatitis C

Interventions

CDI-31244

DRUG

Placebo

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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