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Hepatitis CPhase 1NCT02760758

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

A Phase 1 study testing CDI-31244 in people with Hepatitis C, run by Cocrystal Pharma, Inc. at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis C
What is being tested?
CDI-31244
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
76 participants
Where
1 siteCanada
Study dates
Apr 2016to Apr 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Algorithme

    Montreal, Quebec

Other trials in Canada

About this study

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

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.

Conditions
Hepatitis C
Being tested
CDI-31244, Placebo
Keywords
non-nucleoside inhibitor, NNI, HCV, DAA
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CDI-31244Drug

    Also called CC-31244

    NNI

  • PlaceboDrug

    Also called CDI-31244 Placebo

    no active ingredients

Study groups in NCT02760758
Study groupRoleWhat they receive
Cohort 1A HVExperimentalCDI-31244 20 mg active or placebo single dose (SD)
Receives: Drug: CDI-31244; Drug: Placebo
Cohort 2A HVExperimentalCDI-31244 50 mg active or placebo SD
Receives: Drug: CDI-31244; Drug: Placebo
Cohort 3A HVExperimentalCDI-31244 100 mg active or placebo SD
Receives: Drug: CDI-31244; Drug: Placebo
Cohort 4A HVExperimentalCDI-31244 200 mg active or placebo SD; food effect
Receives: Drug: CDI-31244; Drug: Placebo
Cohort 5A HVExperimentalCDI-31244 400 mg active or placebo SD
Receives: Drug: CDI-31244; Drug: Placebo
Cohort 6A HVExperimentalCDI-31244 200 mg active or placebo multiple dose (MD)
Receives: Drug: CDI-31244; Drug: Placebo
Cohort 7A HVExperimentalCDI-31244 200 mg active or placebo MD
Receives: Drug: CDI-31244; Drug: Placebo
Cohort 8A HVExperimentalCDI-31244 400 mg active or placebo MD
Receives: Drug: CDI-31244; Drug: Placebo
Cohort 1B HCV genotype (GT) 1ExperimentalCDI-31244 400 mg active or placebo MD
Receives: Drug: CDI-31244; Drug: Placebo
Cohort 2B HCV GT 1ExperimentalCDI-31244 600 mg active or placebo MD
Receives: Drug: CDI-31244; Drug: Placebo
Cohort 3B HCV GT 1ExperimentalCDI-31244 800 mg active or placebo MD
Receives: Drug: CDI-31244; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Day 1 to Day 35

Secondary outcomes (5)

  1. Measure plasma levels of CDI-31244 after SD

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Day 1 to 35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionMar 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
76 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02760758
Sponsor's protocol ID
CDI-31244-P1-001
Status last verified
Aug 2016
First submitted
27 Apr 2016
Last updated
20 Apr 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CDI-31244 in people with Hepatitis C, run by Cocrystal Pharma, Inc. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of treatment emergent adverse events (AE) (time frame: Day 1 to Day 35). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02760758.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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