Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects.
IND Number: 100,932/79,599/101,943
Primary Purpose:
Other: Phase 1 clinical pharmacology bioavailability study to assess food effect
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: DCV 3DAA FDC fasted state | Experimental | DCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state |
|
| Treatment B: DCV 3DAA FDC with high-fat meal | Experimental | DCV 3DAA FDC tablet by mouth once on specified days with high-fat meal |
|
| Treatment C: DCV 3DAA FDC with light meal | Experimental | DCV 3DAA FDC tablet by mouth once on specified days with light meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCV 3DAA FDC | Drug | Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325 | Day 1 to Day 13 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325 | Day 1 to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for DCV, ASV and BMS-791325 | Day 1 to Day 13 | |
| Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325 | Day 1 to Day 13 |
Not provided
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Any significant acute or chronic medical illness
Current or recent (within 3 months of study drug administration) gastrointestinal disease
Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy
History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease
Use of tobacco-containing or nicotine-containing products
Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat:
Any of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Discoveries, Llc D/B/A Icon Development Solutions | San Antonio | Texas | 78209 | United States |
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325 | Day 1 to Day 13 |
| AUC(0-T) for BMS-794712 | Day 1 to Day 13 |
| AUC(INF) for BMS-794712 | Day 1 to Day 13 |
| Cmax for BMS-794712 | Day 1 to Day 13 |
| Tmax for BMS-794712 | Day 1 to Day 13 |
| T-HALF for BMS-794712 | Day 1 to Day 13 |
| Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation | Day 1 to Day 13 |
| Safety measured by abnormalities in vital sign measurements | Day 1 to Day 13 |
| Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations | Day 1 to Day 13 |
| Safety measured by marked abnormalities in clinical laboratory test results | Day 1 to Day 13 |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |