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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004645-17 | EudraCT Number |
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The purpose of this study is to determine the absolute bioavailability of 150 mg oral dose of BMS-791325 relative to 100 µg IV infusion of [13C]-BMS-791325.
Primary Purpose: Other: Protocol is designed to assess the absolute bioavailability of 150 mg (2x75 mg tablets) BMS-791325 administered orally
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-791325 (oral) and [13C]-BMS-791325 (IV) | Experimental | BMS-791325 single dose tablet orally and [13C]-BMS-791325 single dose solution intravenously on specific days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-791325 | Drug |
| ||
| [13C]-BMS-791325 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute oral bioavailability (F) of BMS-791325 | Absolute bioavailability of 150 mg (2x75 mg tablets) BMS-791325 administered orally will be established by calculating the ratio of the dose normalized AUC(INF) of oral dose with that of 100 µg IV infused dose. | 48 hours from time of oral dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of BMS-791325 by the occurrence of AEs and SAEs, abnormalities in vital sign measurements exceeding pre-defined thresholds, findings on ECGs and PEs, and abnormalities and marked abnormalities in clinical laboratory test. | Serious adverse events (SAEs) Adverse events (AEs) Physical examinations (PEs) | Day 1 predose and 2 hours post-dose, Day 2 and Day 3 |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Men and women ages 18 to 49 years, inclusive
Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding
Exclusion Criteria:
i)PR ≥ 210 msec
ii)QRS ≥ 120 msec
iii)QT ≥ 500 msec
iv)QTcF ≥ 450 msec
v)Second or third degree heart block
h) Positive urine screen for drugs of abuse
i) Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, r HIV-1, -2 antibodies
j) Any of the following screening or Day -1 laboratory results outside the ranges specified below as defined by the laboratory, confirmed by repeat analysis:
i)Serum creatinine > upper limit of normal (ULN)
ii)Alanine aminotransferase (ALT) > ULN
iii)Aspartate aminotransferase(AST) > ULN
iv)Total bilirubin > ULN
k) History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Nottingham | Nottinghamshire | NG11 6JS | United Kingdom |
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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 |
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| Drug |
|
| Maximum observed plasma concentration (Cmax) of BMS-791325 (oral dose) and [13C]-BMS-791325 (IV dose) | Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose |
| Time of maximum observed plasma concentration (Tmax) of BMS-791325 (oral dose) and [13C]-BMS-791325 (IV dose) | Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-791325 (oral dose) and [13C]-BMS-791325 (IV dose) | Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-791325 (oral dose) and [13C]-BMS-791325 (IV dose) | Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose |
| Terminal plasma half-life (T-HALF) of BMS-791325 (oral dose) and [13C]-BMS-791325 (IV dose) | Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose |
| Total clearance (CLT) of [13C]-BMS-791325 (IV dose) | Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose |
| Volume of distribution at steady-state (Vss) of [13C]-BMS-791325 (IV dose) | Pre-dose and at 0.5, 1, 1.5, 1.75, 1.97, 2, 2.125, 2.25, 2.5, 2.75, 3, 4, 5, 6, 8, 10, 12, 16, 24, 28, 32, 36 and 48 hours post oral dose |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |