Hepatitis CPhase 1/2INH-189-006NCT01445795
Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects
A Phase 1/2 study testing 200 mg INX-08189 Fasted, 100 mg INX-08189 QD and 100 mg INX-08189 with low-fat meal in people with Hepatitis C, run by Bristol-Myers Squibb at 2 sites in 2 countries.
Trial summary
This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a study of the food effect in Chronically-infected Genotype 1 Hepatitis C Virus (HCV), Treatment-naïve subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- 200 mg INX-08189 Fasted, 100 mg INX-08189 QD and 100 mg INX-08189 with low-fat meal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2011to May 2012
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening visit (Visit 1), subject criteria:
- Males and females, 18 to 65 years of age inclusive with a body mass index (BMI) of at least 18 kg/m2 but not exceeding 36 kg/m2;
- Diagnosed with chronic HCV by at least 1 previous polymerase chain reaction (PCR) result prior to Visit 1 (screening), with a positive HCV viral load of least 100,000 IU/ml at Visit 1 (screening) as measured by quantitative PCR;
- HCV genotype 1 per laboratory testing report;
- HCV treatment-naïve where "treatment-naïve" is defined as no prior treatment with interferon alpha, pegylated interferon alpha, ribavirin, or any HCV direct acting anti-viral drugs;
- Liver biopsy consistent with chronic HCV infection but with a classification of non-cirrhotic as judged by a pathologist (defined as Knodell ≤ 3, Metavir ≤ 2, Ishak ≤ 4, or Batts \& Ludwig ≤ 2) within the last 2 years and before Visit 2 (biopsy can be done within the screening period);
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- Negative urine drug screen for drugs of abuse (see Appendix B; note: methadone is not allowed);
- Females will have a negative serum beta human chorionic gonadotropin (βHCG) pregnancy test at screening and a negative urine dipstick pregnancy test upon entry to the clinical unit on Study Day -1;
- Agreement by both female subjects of childbearing potential and male subjects (who have not been surgically sterilized) to practice an acceptable method of birth control, which includes at least 1 barrier during the study and at least 6 months after cessation of treatment. Surgical sterilization of either the female or the male must have occurred at least 6 month prior to first dose and females must be post-menopausal for 2 years to be considered non-child-bearing potential.
- Willing and able to complete all study visits and procedures, and able to effectively communicate with the Investigator and other testing center personnel;
- Signed informed consent form (ICF) executed prior to protocol screening assessments
Who cannot join
- screening visit (Visit1), subject criteria:
- Advanced liver disease, cirrhosis, or signs of decompensated liver disease such as variceal bleeding, ascites, hepatic encephalopathy, active jaundice defined by a total bilirubin > 2, or other evidence of decompensated liver disease;
- Co-infection with hepatitis B virus (HBV)or human immunodeficiency virus (HIV) (positive test for hepatitis B surface antigen [HBsAg] or anti-HIV antibody [Ab]);
- Acute cardiac ischemia, unstable heart disease or clinically symptomatic cardiac abnormalities apparent on electrocardiogram (ECG) and physical exam, or a QTcF interval at Visit 1 of ≥ 450 ms by Fridericia's correction, or a personal or family history of Torsades de pointes;
- Use of the following medications concurrently or within the 30 days prior Screening (Visit 1) associated with QT prolongation: macrolides, antiarrhythmic agents, azoles, fluoroquinolones, and tricyclic anti-depressants (note: methadone use is not allowed);
- Use of immunosuppressive or immune-modulating agents (including corticosteroids and immunosuppressive agents) or presence of an immunologically-mediated autoimmune disease (other than asthma) or history of solid organ or bone marrow transplantation (note: inhaled steroids for asthma and topical steroid for minor skin conditions allowed and washout period for PO/IM/IV corticosteroid use is 8 weeks; washout periods for other immunosuppressives determined by Medical Monitor);
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- Use of strong Cytochrome P (CYP)3A4-inhibiting protease inhibitors (specifically atazanavir, indinavir, nelfinavir, saquinavir, and ritonavir), strong CYP3A4 inhibitors (specifically clarithromycin, itraconazole, ketoconazole, nefazodone, telithromycin), or strong CYP3A4 inducers (specifically rifampin, efavirenz, etravirine, phenobarbital, phenytoin, and carbamazepine);
- Absolute neutrophil count of < 1,800 cells/mm3, or platelet count < 130,000 cells/mm3, or hemoglobin < 12 g/dl for women and < 13 g/dl for men, or a history of anemia, sickle cell anemia, or thalassemia; (note: if baseline value within 5% of minimum qualifying value, 1 re-test allowed for the purpose of qualifying for study);
- A history of abnormal thyroid function that is not adequately controlled (defined as thyroid stimulating hormone [TSH] levels < 0.8 x lower limit of normal [LLN] or > 1.2 x the upper limit of normal [ULN]);
- Serum creatinine concentration ≥ 1.5 times the upper limit of normal, or albumin ≤ 3 g/dl;
- Any history of suicide attempt, receipt of professional counseling for suicidal ideation or any current suicidal ideation, or other serious psychiatric disorders (ie, bipolar disorder, severe depression, psychosis) requiring or having required hospitalization or medication
- Any malignancy within the last 5 years other than treated cervical carcinoma in situ or treated basal cell carcinoma with no more than 20% risk of recurrence within 2 years;
- Alcohol abuse within the past 2 years or an alcohol use pattern that will interfere with the study conduct;
- Drug abuse within the last 6 months.
- Current lactation or breastfeeding;
- Major surgery within 30 days prior Visit 1;
- Participation in another clinical trial of an investigational drug or device within 6 months prior to visit 1 unless that prior participation involved exposure only to placebo by clear and available documentation;
- Donation of blood or plasma within 30 days prior to Visit 1.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multi-center, Placebo-controlled, Multiple Dose, Study of the Safety and Pharmacokinetics and Pharmacodynamics of INX-08189 Dosed Either QD, BID or Adjunctively With Ribavirin, and a Study of the Food Effect, in Chronically-infected Genotype 1 HCV, Treatment-naïve Subjects
This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a study of the food effect in Chronically-infected Genotype 1 Hepatitis C Virus (HCV), Treatment-naïve subjects.
Read the detailed description
Primary Objectives:
To evaluate in chronically-infected, non-cirrhotic, genotype 1 treatment naïve-subjects dosed with Study Drug for 7 consecutive days
Safety
- The safety of each of the 4 dosing cohorts of INX-08189 (200 mg daily (QD), 100 mg twice a day (BID), 100 mg QD with low-fat meal, and 100 mg QD with adjunctive ribavirin).
Pharmacokinetic
- To characterize the pharmacokinetic (PK) profile of oral doses of INX-08189 (200 mg QD, 100 mg BID, 100 mg QD with low-fat meal, and 100 mg QD with adjunctive ribavirin) and the PK profile of the metabolite (INX-08032).
Pharmacodynamic
- To evaluate the relationship between the kinetics of the reduction from baseline in serum HCV RNA and PK parameters of INX-08189 and the metabolite INX-08032
Efficacy
- To measure the kinetics of viral load reduction in plasma HCV RNA by each of the 4 dosing cohorts of INX-08189 (200 mg QD, 100 mg BID, 100 mg QD with low-fat meal, and 100 mg QD with adjunctive ribavirin).
- Conditions
- Hepatitis C
- Being tested
- 200 mg INX-08189 Fasted, Placebo QD Fasted, 100 mg INX-08189 QD, Placebo QD, 100 mg INX-08189 with low-fat meal
- Keywords
- Inhibitex, Chronic Hepatitis, Hepatitis C Virus
- Medical subject headings
- Hepatitis C, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg INX-08189 FastedDrug
200 mg capsule INX-08189 fasted x7 days
Placebo QD FastedDrug
Placebo capsule QD fasted x7 days
100 mg INX-08189 QDDrug
100 mg INX-08189 capsule QD x 7 days
Placebo QDDrug
Placebo capsule Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID)
100 mg INX-08189 with low-fat mealDrug
INX-08189 100 mg capsule, with low-fat meal QD for seven days
Placebo with low-fat mealDrug
Placebo capsule administered with a low-fat meal QD for seven days
100 mg INX-08189 BID FastedDrug
100 mg INX-08189 BID fasted x7 days
Placebo BID FastedDrug
Placebo BID fasted x7 days
ribavirinDrug
| Study group | Role | What they receive |
|---|---|---|
| 200 mg INX-08189 Fasted | Experimental | Cohort 1: 200 mg INX-08189 QD fasted for seven days Receives: Drug: 200 mg INX-08189 Fasted |
| Placebo QD Fasted | Placebo comparator | Cohort 1: Placebo QD fasted for seven days Receives: Drug: Placebo QD Fasted |
| 100 mg INX-08189 with Ribavirin | Experimental | Cohort 2: 100 mg INX-08189 100 mg dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID, the AM dose will be taken 4 hours after INX-08189 so it may be taken with food) Receives: Drug: 100 mg INX-08189 QD; Drug: ribavirin |
| Placebo QD dosed with ribavirin | Active comparator | Cohort 2: Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID) Receives: Drug: Placebo QD |
| 100 mg INX-08189 with a low-fat meal | Experimental | Cohort 3: 100 mg INX-08189 with a low-fat meal QD x7 days Receives: Drug: 100 mg INX-08189 with low-fat meal |
| Placebo with low-fat meal | Placebo comparator | Cohort 3: Placebo administered with a low-fat meal QD for 7 days Receives: Drug: Placebo with low-fat meal |
| 100 mg INX-08189 Fasted | Experimental | Cohort 4: 100 mg INX-08189 BID fasted x7 days Receives: Drug: 100 mg INX-08189 BID Fasted |
| Placebo BID Fasted | Placebo comparator | Cohort 4: Placebo BID fasted x7 days Receives: Drug: Placebo BID Fasted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HCV RNA 24 hours following the final dose of Study Drug (INX-08189/placebo)
Measured: 24 hours following the final dose of Study Drug
Secondary outcomes (1)
Change in HCV RNA over time during the 7 days of dosing and during the follow-up period and the maximum change from baseline in HCV RNA.
Measured: HCV RNA will be measured at the following time points: Once each at Screening (Visit1), Study Day 10 (Visit 12), and Study Day 14 (Visit 13). Samples will be taken for HCV analysis pre-dose, and at 12, 24 and 48 hours after the first dose of Study Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionMay 2012
- Study completionMay 2012
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.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445795
- Sponsor's protocol ID
- AI472-006
- Other IDs
- INH-189-006
- Acronym
- INH-189-006
- Status last verified
- Jun 2016
- First submitted
- 27 Sep 2011
- Last updated
- 27 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Placebo-controlled, Multiple Dose, Study of the Safety and Pharmacokinetics and Pharmacodynamics of INX-08189 Dosed Either QD, BID or Adjunctively With Ribavirin, and a Study of the Food Effect, in Chronically-infected Genotype 1 HCV, Treatment-naïve Subjects
- ClinicalTrials.gov ID
- NCT01445795
- Acronym / sponsor ID
- INH-189-006 / AI472-006
- Conditions
- Hepatitis C
- Keywords
- Inhibitex, Chronic Hepatitis, Hepatitis C Virus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Oct 2011 (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 study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a study of the food effect in Chronically-infected Genotype 1 Hepatitis C Virus (HCV), Treatment-naïve subjects.
Detailed description
Primary Objectives:
To evaluate in chronically-infected, non-cirrhotic, genotype 1 treatment naïve-subjects dosed with Study Drug for 7 consecutive days
Safety
- The safety of each of the 4 dosing cohorts of INX-08189 (200 mg daily (QD), 100 mg twice a day (BID), 100 mg QD with low-fat meal, and 100 mg QD with adjunctive ribavirin).
Pharmacokinetic
- To characterize the pharmacokinetic (PK) profile of oral doses of INX-08189 (200 mg QD, 100 mg BID, 100 mg QD with low-fat meal, and 100 mg QD with adjunctive ribavirin) and the PK profile of the metabolite (INX-08032).
Pharmacodynamic
- To evaluate the relationship between the kinetics of the reduction from baseline in serum HCV RNA and PK parameters of INX-08189 and the metabolite INX-08032
Efficacy
- To measure the kinetics of viral load reduction in plasma HCV RNA by each of the 4 dosing cohorts of INX-08189 (200 mg QD, 100 mg BID, 100 mg QD with low-fat meal, and 100 mg QD with adjunctive ribavirin).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 200 mg INX-08189 Fasted | Experimental | Drug: 200 mg INX-08189 FastedCohort 1: 200 mg INX-08189 QD fasted for seven days |
| Placebo QD Fasted | Placebo comparator | Drug: Placebo QD FastedCohort 1: Placebo QD fasted for seven days |
| 100 mg INX-08189 with Ribavirin | Experimental | Drug: 100 mg INX-08189 QD, Drug: ribavirinCohort 2: 100 mg INX-08189 100 mg dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID, the AM dose will be taken 4 hours after INX-08189 so it may be taken with food) |
| Placebo QD dosed with ribavirin | Active comparator | Drug: Placebo QDCohort 2: Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID) |
| 100 mg INX-08189 with a low-fat meal | Experimental | Drug: 100 mg INX-08189 with low-fat mealCohort 3: 100 mg INX-08189 with a low-fat meal QD x7 days |
| Placebo with low-fat meal | Placebo comparator | Drug: Placebo with low-fat mealCohort 3: Placebo administered with a low-fat meal QD for 7 days |
| 100 mg INX-08189 Fasted | Experimental | Drug: 100 mg INX-08189 BID FastedCohort 4: 100 mg INX-08189 BID fasted x7 days |
| Placebo BID Fasted | Placebo comparator | Drug: Placebo BID FastedCohort 4: Placebo BID fasted x7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Males and females, 18 to 65 years of age inclusive with a body mass index (BMI) of at least 18 kg/m2 but not exceeding 36 kg/m2;
- Diagnosed with chronic HCV by at least 1 previous polymerase chain reaction (PCR) result prior to Visit 1 (screening), with a positive HCV viral load of least 100,000 IU/ml at Visit 1 (screening) as measured by quantitative PCR;
- HCV genotype 1 per laboratory testing report;
- HCV treatment-naïve where "treatment-naïve" is defined as no prior treatment with interferon alpha, pegylated interferon alpha, ribavirin, or any HCV direct acting anti-viral drugs;
- Liver biopsy consistent with chronic HCV infection but with a classification of non-cirrhotic as judged by a pathologist (defined as Knodell ≤ 3, Metavir ≤ 2, Ishak ≤ 4, or Batts \& Ludwig ≤ 2) within the last 2 years and before Visit 2 (biopsy can be done within the screening period);
Key exclusion criteria (18 listed)
- Advanced liver disease, cirrhosis, or signs of decompensated liver disease such as variceal bleeding, ascites, hepatic encephalopathy, active jaundice defined by a total bilirubin > 2, or other evidence of decompensated liver disease;
- Co-infection with hepatitis B virus (HBV)or human immunodeficiency virus (HIV) (positive test for hepatitis B surface antigen [HBsAg] or anti-HIV antibody [Ab]);
- Acute cardiac ischemia, unstable heart disease or clinically symptomatic cardiac abnormalities apparent on electrocardiogram (ECG) and physical exam, or a QTcF interval at Visit 1 of ≥ 450 ms by Fridericia's correction, or a personal or family history of Torsades de pointes;
- Use of the following medications concurrently or within the 30 days prior Screening (Visit 1) associated with QT prolongation: macrolides, antiarrhythmic agents, azoles, fluoroquinolones, and tricyclic anti-depressants (note: methadone use is not allowed);
- Use of immunosuppressive or immune-modulating agents (including corticosteroids and immunosuppressive agents) or presence of an immunologically-mediated autoimmune disease (other than asthma) or history of solid organ or bone marrow transplantation (note: inhaled steroids for asthma and topical steroid for minor skin conditions allowed and washout period for PO/IM/IV corticosteroid use is 8 weeks; washout periods for other immunosuppressives determined by Medical Monitor);
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 |
|---|---|---|
| 200 mg INX-08189 Fasted200 mg capsule INX-08189 fasted x7 days | Drug | 200 mg INX-08189 Fasted |
| Placebo QD FastedPlacebo capsule QD fasted x7 days | Drug | Placebo QD Fasted |
| 100 mg INX-08189 QD100 mg INX-08189 capsule QD x 7 days | Drug | 100 mg INX-08189 with Ribavirin |
| Placebo QDPlacebo capsule Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID) | Drug | Placebo QD dosed with ribavirin |
| 100 mg INX-08189 with low-fat mealINX-08189 100 mg capsule, with low-fat meal QD for seven days | Drug | 100 mg INX-08189 with a low-fat meal |
| Placebo with low-fat mealPlacebo capsule administered with a low-fat meal QD for seven days | Drug | Placebo with low-fat meal |
| 100 mg INX-08189 BID Fasted100 mg INX-08189 BID fasted x7 days | Drug | 100 mg INX-08189 Fasted |
| Placebo BID FastedPlacebo BID fasted x7 days | Drug | Placebo BID Fasted |
| ribavirin | Drug | 100 mg INX-08189 with Ribavirin |
Primary outcome
Change from baseline in HCV RNA 24 hours following the final dose of Study Drug (INX-08189/placebo)
Time frame: 24 hours following the final dose of Study Drug
1 secondary outcome
Change in HCV RNA over time during the 7 days of dosing and during the follow-up period and the maximum change from baseline in HCV RNA.
Time frame: HCV RNA will be measured at the following time points: Once each at Screening (Visit1), Study Day 10 (Visit 12), and Study Day 14 (Visit 13). Samples will be taken for HCV analysis pre-dose, and at 12, 24 and 48 hours after the first dose of Study Drug
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 27 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 200 mg INX-08189 Fasted, 100 mg INX-08189 QD and 100 mg INX-08189 with low-fat meal in people with Hepatitis C, run by Bristol-Myers Squibb at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. 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 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in HCV RNA 24 hours following the final dose of Study Drug (INX-08189/placebo) (time frame: 24 hours following the final dose of Study Drug). 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 27 Jun 2016.