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The purpose of this study is to assess the effect of Daclatasvir, Asunaprevir, and BMS-791325 on the pharmacokinetics of selective serotonin reuptake inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 2 | Experimental | Sertraline (50 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Sertraline (50 milligrams each morning) days 23-29 |
|
| Cohort 1 | Experimental | Escitalopram (10 milligrams each morning) day 1-7, DCV 3DAA FDC + 75 mg BMS-791325 twice daily days 13 to 22, DCV 3DAA FDC + 75 mg BMS-791325 twice daily + Escitalopram (10 milligrams each morning) days 23-29 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 10 milligrams administered each morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serial blood samples for plasma SSRI (selective serotonin reuptake inhibitor) of escitalopram or sertraline | Before dosing (0 hour) through 24 hours after SSRI administration on day 7 and day 29 | |
| Serial blood samples for determination of plasma concentrations of DCV (daclatasvir), ASV (asunaprevir), BMS-791325, and the metabolite BMS-794712 | Before dosing (0 hour) through 12 hours after SSRI administration on day 22 and day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessments based on review of adverse events, vital sign measurements, electrocardiograms, physical examinations, and clinical laboratory tests. | Two to three months |
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Inclusion Criteria:
Signed Informed Consent Form
a) Signed written informed consent must be obtained from the subjects in accordance with requirements of the study center's IRB or IEC before the initiation of any protocol-required procedures.
Target Population
a) Healthy subjects as determined by no clinically significant deviation from normal in medical history, psychiatric history, physical examination findings, vital sign measurements, 12-lead ECG measurements, physical measurements, and clinical laboratory test results.
Age and Reproductive Status
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ikenna Ogbaa, MD | PPD Development, LP | Principal Investigator |
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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 |
|---|---|
| D000089983 | Escitalopram |
| D020280 | Sertraline |
| 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 |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Sertraline | Drug | 50 milligrams administered each morning |
|
|
| DCV 3DAA FDC | Drug | Fixed dose combination (daclatasvir [DCV] 30 milligrams, asunaprevir [ASV] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily |
|
| BMS-791325 | Drug | 75 milligrams single-agent film coated oral tablet administered twice daily |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015057 | 1-Naphthylamine |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |