Hepatitis CPhase 1NCT02084953
Study to Determine the Effect of BMS-791325 on the ECG QTcF Interval in Healthy Subjects
A Phase 1 study testing BMS-791325 and Moxifloxacin in people with Hepatitis C, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to determine whether BMS-791325 has an effect on the electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF). Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- BMS-791325 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2014
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men and women, ages 18 to 49 yr old
- BMI 18 to 32
- Women must not be pregnant or breastfeeding
Who cannot join
- Any significant acute or chronic medical illness
- A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
- History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
- History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
- Inability to swallow multiple tablets consecutively
- Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration: PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec, Heart Rate (HR) < 45 bpm
Show all 11Show fewer
- Second or third degree heart block prior to study drug
- Positive urine screen for drugs of abuse
- Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody
- Any of the following lab results outside of the ranges specified below prior to dosing: Alanine aminotransferase (ALT) > upper limit of normal (ULN), Aspartate aminotransferase (AST) > ULN, Total bilirubin > ULN, Direct bilirubin > ULN, Creatinine > ULN, Serum potassium < lower limit of normal (LLN), Serum magnesium < LLN
- History of allergy to Moxifloxacin, BMS-791325, nonstructural protein 5B (NS5B) non-nucleoside inhibitors or related compounds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blinded, Positive-Controlled, Placebo-Controlled, 3-Way Crossover Study to Determine the Electrocardiographic Effects of BMS-791325 in Healthy Subjects
The purpose of this study is to determine whether BMS-791325 has an effect on the electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).
Read the detailed description
Primary Purpose: Other: This Phase 1 study is a clinical pharmacology thorough QT study.
- Conditions
- Hepatitis C
- Being tested
- BMS-791325, Moxifloxacin, Placebo matching BMS-791325
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-791325Drug
MoxifloxacinDrug
Also called Avelox®
Placebo matching BMS-791325Drug
| Study group | Role | What they receive |
|---|---|---|
| ARM A: BMS-791325 | Experimental | BMS-791325 600 mg tablet orally on 1st and 2nd day, then 900 mg on the 3rd day once a day for 3 days Receives: Drug: BMS-791325 |
| ARM B: Moxifloxacin | Active comparator | Moxifloxacin 400mg tablet orally once on third day Receives: Drug: Moxifloxacin |
| ARM C: Placebo matching BMS-791325 | Placebo comparator | Placebo matching BMS-791325 0 mg tablet orally once daily for 3 days Receives: Drug: Placebo matching BMS-791325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference from placebo of BMS-791325 in time-matched change from baseline (Day -1 on the study) to Day 3 of each period (ΔΔQTcF) at postdose extraction times for the QTcF
Measured: Approximately 28 days
Secondary outcomes (11)
ΔΔHR, ΔΔPR, ΔΔQRS, ΔΔQT
Difference from placebo in time-matched change from baseline (Day -1) to Day 3 at postdose extraction times in the ECG-derived RR or HR and other ECG intervals (PR, QRS, QT). QT is the unadjusted QT interval
Measured: Approximately 28 days
Number and percent of subjects having a within-period maximum HR, PR, QRS, QT, QTcF, ΔQT and ΔQTcF within prespecified categories
Measured: Approximately 28 days
Relationship between plasma concentrations of BMS-791325, BMS-794712, and BMS-948158, and the corresponding ΔΔQTcF
Measured: Approximately 28 days
Maximum observed concentration (Cmax) of BMS-791325, BMS-794712, and BMS-948158
Measured: 43 timepoints up to day 26
Time of maximum observed concentration (Tmax) of BMS-791325, BMS-794712, and BMS-948158
Measured: 43 timepoints up to day 26
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-791325, BMS-794712, and BMS-948158
Measured: 43 timepoints up to day 26
Apparent total oral clearance (CLT/F) of BMS-791325, BMS-794712, and BMS-948158
Measured: 43 timepoints up to day 26
Terminal phase plasma half life (T-HALF) of BMS-791325, BMS-794712, and BMS-948158
Measured: 43 timepoints up to day 26
AUC(TAU) metabolic ratios of BMS-791325, BMS-794712, and BMS-948158
Measured: 43 timepoints up to day 26
Incidence of AEs, SAEs, AEs leading to discontinuation and death, marked laboratory abnormalities, findings on 12-lead safety ECG measurements and physical examination, and abnormalities in vital sign measurements exceeding pre-defined thresholds
Adverse event (AEs)
Serious adverse event (SAEs)
Measured: Up to day 28
Difference from placebo of Moxifloxacin in change from baseline (Day -1) to Day 3 at postdose extraction times for the QTcF (ΔΔQTcF)
Measured: Approximately 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionMay 2014
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 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
- NCT02084953
- Sponsor's protocol ID
- AI443-112
- Status last verified
- Jul 2014
- First submitted
- 10 Mar 2014
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Positive-Controlled, Placebo-Controlled, 3-Way Crossover Study to Determine the Electrocardiographic Effects of BMS-791325 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02084953
- Acronym / sponsor ID
- AI443-112
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Mar 2014 (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 whether BMS-791325 has an effect on the electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).
Detailed description
Primary Purpose: Other: This Phase 1 study is a clinical pharmacology thorough QT study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM A: BMS-791325 | Experimental | Drug: BMS-791325BMS-791325 600 mg tablet orally on 1st and 2nd day, then 900 mg on the 3rd day once a day for 3 days |
| ARM B: Moxifloxacin | Active comparator | Drug: MoxifloxacinMoxifloxacin 400mg tablet orally once on third day |
| ARM C: Placebo matching BMS-791325 | Placebo comparator | Drug: Placebo matching BMS-791325Placebo matching BMS-791325 0 mg tablet orally once daily for 3 days |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men and women, ages 18 to 49 yr old
- BMI 18 to 32
- Women must not be pregnant or breastfeeding
Key exclusion criteria (11 listed)
- Any significant acute or chronic medical illness
- A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
- History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
- History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
- Inability to swallow multiple tablets consecutively
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-791325 | Drug | ARM A: BMS-791325 |
| MoxifloxacinAlso: Avelox® | Drug | ARM B: Moxifloxacin |
| Placebo matching BMS-791325 | Drug | ARM C: Placebo matching BMS-791325 |
Primary outcome
Difference from placebo of BMS-791325 in time-matched change from baseline (Day -1 on the study) to Day 3 of each period (ΔΔQTcF) at postdose extraction times for the QTcF
Time frame: Approximately 28 days
11 secondary outcomes
ΔΔHR, ΔΔPR, ΔΔQRS, ΔΔQT
Time frame: Approximately 28 days
Number and percent of subjects having a within-period maximum HR, PR, QRS, QT, QTcF, ΔQT and ΔQTcF within prespecified categories
Time frame: Approximately 28 days
Relationship between plasma concentrations of BMS-791325, BMS-794712, and BMS-948158, and the corresponding ΔΔQTcF
Time frame: Approximately 28 days
Maximum observed concentration (Cmax) of BMS-791325, BMS-794712, and BMS-948158
Time frame: 43 timepoints up to day 26
Time of maximum observed concentration (Tmax) of BMS-791325, BMS-794712, and BMS-948158
Time frame: 43 timepoints up to day 26
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-791325, BMS-794712, and BMS-948158
Time frame: 43 timepoints up to day 26
Apparent total oral clearance (CLT/F) of BMS-791325, BMS-794712, and BMS-948158
Time frame: 43 timepoints up to day 26
Terminal phase plasma half life (T-HALF) of BMS-791325, BMS-794712, and BMS-948158
Time frame: 43 timepoints up to day 26
AUC(TAU) metabolic ratios of BMS-791325, BMS-794712, and BMS-948158
Time frame: 43 timepoints up to day 26
Incidence of AEs, SAEs, AEs leading to discontinuation and death, marked laboratory abnormalities, findings on 12-lead safety ECG measurements and physical examination, and abnormalities in vital sign measurements exceeding pre-defined thresholds
Time frame: Up to day 28
Difference from placebo of Moxifloxacin in change from baseline (Day -1) to Day 3 at postdose extraction times for the QTcF (ΔΔQTcF)
Time frame: Approximately 28 days
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 28 Jul 2014.
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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
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 BMS-791325 and Moxifloxacin in people with Hepatitis C, run by Bristol-Myers Squibb at 1 site in United States.
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 3 inclusion and 11 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 28 Jul 2014. 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 United States. 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 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?
Difference from placebo of BMS-791325 in time-matched change from baseline (Day -1 on the study) to Day 3 of each period (ΔΔQTcF) at postdose extraction times for the QTcF (time frame: Approximately 28 days). 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 28 Jul 2014.