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The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive agent.
IND Number: 79,599 and 101,943
Other: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325 | Experimental | Cycle 1- Low dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days Cycle 2- High dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days and High dose FDC of Norethindrone and Ethinyl Estradiol + FDC of Daclatasvir, Asunaprevir and BMS-791325 + BMS-791325 tablets orally on specified days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FDC of Daclatasvir, Asunaprevir and BMS-791325 | Drug |
| ||
| FDC of Norethindrone and Ethinyl Estradiol |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone | Day 21 to Day 49 | |
| Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone | Day 21 to Day 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-normalized area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone | Day 1 to Day 50 | |
| Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone |
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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 |
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| Drug |
|
|
| BMS-791325 | Drug |
|
| Day 1 to Day 50 |
| Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone | Day 1 to Day 50 |
| Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation | Day 1 to Day 50 |
| Safety measured by abnormalities in vital sign measurements | Day 1 to Day 50 |
| Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations | Day 1 to Day 50 |
| Safety measured by marked abnormalities in clinical laboratory test results | Day 1 to Day 50 |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C571889 | asunaprevir |
| 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 |
| D004997 | Ethinyl Estradiol |
| C020416 | norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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