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.
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.
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 group | Role | What they receive |
|---|---|---|
| Cohort 1A HV | Experimental | CDI-31244 20 mg active or placebo single dose (SD) Receives: Drug: CDI-31244; Drug: Placebo |
| Cohort 2A HV | Experimental | CDI-31244 50 mg active or placebo SD Receives: Drug: CDI-31244; Drug: Placebo |
| Cohort 3A HV | Experimental | CDI-31244 100 mg active or placebo SD Receives: Drug: CDI-31244; Drug: Placebo |
| Cohort 4A HV | Experimental | CDI-31244 200 mg active or placebo SD; food effect Receives: Drug: CDI-31244; Drug: Placebo |
| Cohort 5A HV | Experimental | CDI-31244 400 mg active or placebo SD Receives: Drug: CDI-31244; Drug: Placebo |
| Cohort 6A HV | Experimental | CDI-31244 200 mg active or placebo multiple dose (MD) Receives: Drug: CDI-31244; Drug: Placebo |
| Cohort 7A HV | Experimental | CDI-31244 200 mg active or placebo MD Receives: Drug: CDI-31244; Drug: Placebo |
| Cohort 8A HV | Experimental | CDI-31244 400 mg active or placebo MD Receives: Drug: CDI-31244; Drug: Placebo |
| Cohort 1B HCV genotype (GT) 1 | Experimental | CDI-31244 400 mg active or placebo MD Receives: Drug: CDI-31244; Drug: Placebo |
| Cohort 2B HCV GT 1 | Experimental | CDI-31244 600 mg active or placebo MD Receives: Drug: CDI-31244; Drug: Placebo |
| Cohort 3B HCV GT 1 | Experimental | CDI-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.
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)
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
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
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
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
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.
- First posted4 May 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Cocrystal Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Judy Pattassery, Study director, Cocrystal Pharma, Inc.
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02760758
- Acronym / sponsor ID
- CDI-31244-P1-001
- Conditions
- Hepatitis C
- Keywords
- non-nucleoside inhibitor, NNI, HCV, DAA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Cocrystal Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A HV | Experimental | Drug: CDI-31244, Drug: PlaceboCDI-31244 20 mg active or placebo single dose (SD) |
| Cohort 2A HV | Experimental | Drug: CDI-31244, Drug: PlaceboCDI-31244 50 mg active or placebo SD |
| Cohort 3A HV | Experimental | Drug: CDI-31244, Drug: PlaceboCDI-31244 100 mg active or placebo SD |
| Cohort 4A HV | Experimental | Drug: CDI-31244, Drug: PlaceboCDI-31244 200 mg active or placebo SD; food effect |
| Cohort 5A HV | Experimental | Drug: CDI-31244, Drug: PlaceboCDI-31244 400 mg active or placebo SD |
| Cohort 6A HV | Experimental | Drug: CDI-31244, Drug: PlaceboCDI-31244 200 mg active or placebo multiple dose (MD) |
| Cohort 7A HV | Experimental | Drug: CDI-31244, Drug: PlaceboCDI-31244 200 mg active or placebo MD |
| Cohort 8A HV | Experimental | Drug: CDI-31244, Drug: PlaceboCDI-31244 400 mg active or placebo MD |
| Cohort 1B HCV genotype (GT) 1 | Experimental | Drug: CDI-31244, Drug: PlaceboCDI-31244 400 mg active or placebo MD |
| Cohort 2B HCV GT 1 | Experimental | Drug: CDI-31244, Drug: PlaceboCDI-31244 600 mg active or placebo MD |
| Cohort 3B HCV GT 1 | Experimental | Drug: CDI-31244, Drug: PlaceboCDI-31244 800 mg active or placebo MD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDI-31244Also: CC-31244NNI | Drug | 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 |
| PlaceboAlso: CDI-31244 Placebono active ingredients | Drug | 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 |
Primary outcome
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
5 secondary outcomes
Measure plasma levels of CDI-31244 after SD
Time frame: 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
Measure plasma levels of CDI-31244 after MD
Time frame: Day 1 to Day 13
Measure HCV viral load through the RNA quantitative test
Time frame: Day 1 to Day 35
Measure HCV mutation through genotyping at baseline and after CDI-31244 dosing
Time frame: Day 1 to 35
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Pattassery study director
Cocrystal Pharma, Inc.
1 site in 1 country: see every site and its status.
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?
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.