Chronic Hepatitis CPhase 1NCT01525212
Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients
A Phase 1 study testing BMS-929075 in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 3 sites in Australia.
Trial summary
The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjects Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- BMS-929075
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesAustralia
- Study dates
- Apr 2012to Feb 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, ages 18 to 65 years, inclusive
- Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy
- HCV genotype 1a or 1b only
- HCV RNA viral load of ≥ 100,000 IU/mL
- Have one of the following: i) Documented Fibrotest score of ≤ 0.72 and AST to platelet ratio index (APRI) ≤ 2; or ii) Documented liver biopsy within 12 months preceding Day 1 showing absence of cirrhosis
- Body Mass Index (BMI) of 18.0 to 35.0 kg/m2, inclusive
Who cannot join
- Any significant acute or chronic medical illness
- History of adrenal gland disease, including but not limited to adrenal insufficiency or Cushing's syndrome
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery that could impact upon the absorption of study drug
- Positive for hepatitis B surface antigen (HBsAg)
Show all 14Show fewer
- Positive for Human Immunodeficiency Virus (HIV) -1 and/or -2 antibodies
- Smoking > 10 cigarettes per day
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 5x upper limit of normal (ULN)
- Total Bilirubin ≥ 1.5x ULN
- Hemoglobin < 10 g/dL
- Platelets < 75,000 cell/μL
- ALC (absolute lymphocyte count) < 1000 cell/μL
- Creatinine clearance (as estimated by method of Cockcroft and Gault) less than 60 mL/min
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Local Institution
Adelaide, South Australia, 5000
Local Institution
Herston, Queensland, 4006
Local Institution
Melbourne, Victoria, 3004
About this study
Official title: Double-Blinded, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of BMS-929075 in Treatment Naive Subjects Infected With Hepatitis C Virus Genotype 1
The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjects
- Conditions
- Chronic Hepatitis C
- Being tested
- BMS-929075, Placebo matching BMS-929075
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-929075Drug
Oral Suspension, ≤ 25 mg, Once daily, 3 days
BMS-929075Drug
Oral Suspension, ≤ 100 mg, Once daily, 3 days
BMS-929075Drug
Oral Suspension, ≤ 400 mg, Once daily, 3 days
BMS-929075Drug
Oral Suspension, (≤ 800 mg, Once daily) OR (≤ 400 mg, Twice daily), 3 days
Placebo matching BMS-929075Drug
Oral Suspension, 0 mg, Once daily, 3 days
Placebo matching BMS-929075Drug
Oral Suspension, 0 mg, (Once daily for ≤ 800 mg group) OR (Twice daily for ≤ 400 mg group), 3 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075 | Experimental | Not described Receives: Drug: BMS-929075; Drug: Placebo matching BMS-929075 |
| Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075 | Experimental | Not described Receives: Drug: BMS-929075; Drug: Placebo matching BMS-929075 |
| Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075 | Experimental | Not described Receives: Drug: BMS-929075; Drug: Placebo matching BMS-929075 |
| Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075 | Experimental | Not described Receives: Drug: BMS-929075; Drug: Placebo matching BMS-929075 |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCV RNA level on Day 4
Measured: Within 4 days after the first dose
Secondary outcomes (12)
Maximum decrease from baseline in plasma HCV RNA levels during the period from Day 1 to Day 28
Measured: Days 1-28
Time course of the change from baseline in plasma HCV RNA levels and the time of maximum decrease during the period of Day 1 through Day 28
Measured: Days 1-28
Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
Measured: Days 1-28 (with SAE from screening to Day 30)
Maximum observed plasma concentration (Cmax) of BMS-929075 derived from plasma concentration versus time
Measured: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Minimum observed plasma concentration (Cmin) of BMS-929075 derived from plasma concentration versus time
Measured: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Trough observed plasma concentration (Ctrough) of BMS-929075 derived from plasma concentration versus time
Measured: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Time of maximum observed plasma concentration (Tmax) of BMS-929075 derived from plasma concentration versus time
Measured: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-929075 derived from plasma concentration versus time
Measured: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Plasma half-life (T-HALF) of BMS-929075 derived from plasma concentration versus time
Measured: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Protein Binding (PB) of BMS-929075 derived from plasma concentration versus time
Measured: Day 3 (0h and 2h)
Fraction of free drug in plasma (fu) of BMS-929075 derived from plasma concentration versus time
Measured: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
The relationship between antiviral activity and measures of exposure to BMS-929075
Measured: Days 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2013 (estimated)
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525212
- Sponsor's protocol ID
- AI457-002
- Status last verified
- Jun 2013
- First submitted
- 31 Jan 2012
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blinded, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of BMS-929075 in Treatment Naive Subjects Infected With Hepatitis C Virus Genotype 1
- ClinicalTrials.gov ID
- NCT01525212
- Acronym / sponsor ID
- AI457-002
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 2 Feb 2012 (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.
The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075 | Experimental | Drug: BMS-929075, Drug: Placebo matching BMS-929075 |
| Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075 | Experimental | Drug: BMS-929075, Drug: Placebo matching BMS-929075 |
| Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075 | Experimental | Drug: BMS-929075, Drug: Placebo matching BMS-929075 |
| Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075 | Experimental | Drug: BMS-929075, Drug: Placebo matching BMS-929075 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women, ages 18 to 65 years, inclusive
- Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy
- HCV genotype 1a or 1b only
- HCV RNA viral load of ≥ 100,000 IU/mL
- Have one of the following: i) Documented Fibrotest score of ≤ 0.72 and AST to platelet ratio index (APRI) ≤ 2; or ii) Documented liver biopsy within 12 months preceding Day 1 showing absence of cirrhosis
Key exclusion criteria (14 listed)
- Any significant acute or chronic medical illness
- History of adrenal gland disease, including but not limited to adrenal insufficiency or Cushing's syndrome
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery that could impact upon the absorption of study drug
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 |
|---|---|---|
| BMS-929075Oral Suspension, ≤ 25 mg, Once daily, 3 days | Drug | Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075 |
| BMS-929075Oral Suspension, ≤ 100 mg, Once daily, 3 days | Drug | Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075 |
| BMS-929075Oral Suspension, ≤ 400 mg, Once daily, 3 days | Drug | Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075 |
| BMS-929075Oral Suspension, (≤ 800 mg, Once daily) OR (≤ 400 mg, Twice daily), 3 days | Drug | Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075 |
| Placebo matching BMS-929075Oral Suspension, 0 mg, Once daily, 3 days | Drug | Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075, Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075, Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075 |
| Placebo matching BMS-929075Oral Suspension, 0 mg, (Once daily for ≤ 800 mg group) OR (Twice daily for ≤ 400 mg group), 3 days | Drug | Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075 |
Primary outcome
HCV RNA level on Day 4
Time frame: Within 4 days after the first dose
12 secondary outcomes
Maximum decrease from baseline in plasma HCV RNA levels during the period from Day 1 to Day 28
Time frame: Days 1-28
Time course of the change from baseline in plasma HCV RNA levels and the time of maximum decrease during the period of Day 1 through Day 28
Time frame: Days 1-28
Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
Time frame: Days 1-28 (with SAE from screening to Day 30)
Maximum observed plasma concentration (Cmax) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Minimum observed plasma concentration (Cmin) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Trough observed plasma concentration (Ctrough) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Time of maximum observed plasma concentration (Tmax) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Plasma half-life (T-HALF) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Protein Binding (PB) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 3 (0h and 2h)
Fraction of free drug in plasma (fu) of BMS-929075 derived from plasma concentration versus time
Time frame: Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
The relationship between antiviral activity and measures of exposure to BMS-929075
Time frame: Days 1-6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-929075 in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 3 sites in Australia.
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 6 inclusion and 14 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: withdrawn, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. 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 was withdrawn before enrolling participants, so there are no results.
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?
HCV RNA level on Day 4 (time frame: Within 4 days after the first dose). 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 21 Jun 2013.