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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).
Primary Purpose: Other: This Phase 1 study is a clinical pharmacology thorough QT study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| ARM B: Moxifloxacin | Active Comparator | Moxifloxacin 400mg tablet orally once on third day |
|
| ARM C: Placebo matching BMS-791325 | Placebo Comparator | Placebo matching BMS-791325 0 mg tablet orally once daily for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-791325 | Drug |
| ||
| Moxifloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Approximately 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Approximately 28 days |
| Number and percent of subjects having a within-period maximum HR, PR, QRS, QT, QTcF, ΔQT and ΔQTcF within prespecified categories |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ppd Development, Llc | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C587012 | 8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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|
|
| Placebo matching BMS-791325 | Drug |
|
| Approximately 28 days |
| Relationship between plasma concentrations of BMS-791325, BMS-794712, and BMS-948158, and the corresponding ΔΔQTcF | Approximately 28 days |
| Maximum observed concentration (Cmax) of BMS-791325, BMS-794712, and BMS-948158 | 43 timepoints up to day 26 |
| Time of maximum observed concentration (Tmax) of BMS-791325, BMS-794712, and BMS-948158 | 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 | 43 timepoints up to day 26 |
| Apparent total oral clearance (CLT/F) of BMS-791325, BMS-794712, and BMS-948158 | 43 timepoints up to day 26 |
| Terminal phase plasma half life (T-HALF) of BMS-791325, BMS-794712, and BMS-948158 | 43 timepoints up to day 26 |
| AUC(TAU) metabolic ratios of BMS-791325, BMS-794712, and BMS-948158 | 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) | 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) | Approximately 28 days |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |