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| Name | Class |
|---|---|
| Basilea Pharmaceutica International Ltd | INDUSTRY |
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The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isavuconazole and oral contraceptive | Experimental | Arm description(as needed): Subjects receive single dose of oral contraceptive consisting of ethinyl estradiol and norethindrone on Days 1 and 13 and oral doses of isavuconazole every 8 hours on Days 9 and 10 followed by a once a day dose in the mornings on Days 11 through 16. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| isavuconazole | Drug | oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) variables for ethinyl estradiol and norethindrone (in plasma): AUCinf , AUClast, and Cmax | AUC from time 0 extrapolated to infinity (AUCinf), Area under the curve (AUC) from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax) | For Days 1 and 13: predose and 12 times post dose; for Days 2, 3, 4, 5, 14, 15, 16, and 17: one time each day |
| Measure | Description | Time Frame |
|---|---|---|
| PK variable for ethinyl estradiol and norethindrone (in plasma): tmax , t1/2 , Vz /F, and CL/F | Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 ), apparent volume of distribution (Vz /F), apparent body clearance after oral dosing (CL/F) | For Days 1 and 13: pre-dose and 12 times post dose; for Days 2, 3, 4, 5, 14, 15, 16, and 17: one time each day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States |
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| Oral Contraceptive (ethinyl estradiol / norethindrone) | Drug | contraceptive pill consisting of ethinyl estradiol and norethindrone |
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| PK variable for isavuconazole (in plasma): Ctrough | trough concentration (Ctrough) | For Day 11: predose; for Days 12 and 13: predose and 12 times post dose; for Day 14 and 15: predose; and for Day 16: predose and 24 hours post dose |
| PK variable for isavuconazole (in plasma): AUCtau, Cmax, and tmax | Area under the concentration-time curve during the time interval between consecutive dosing (AUCtau) | For Days 12 and 13: predose and 12 times post dose |
| Safety assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) | Day 1 through Day 24 ± 2 days |
| ID | Term |
|---|---|
| C508735 | isavuconazole |
| D003276 | Contraceptives, Oral |
| D004997 | Ethinyl Estradiol |
| D009640 | Norethindrone |
| C014715 | Norinyl |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| 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 |
| D009652 | Norpregnenes |
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