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| Name | Class |
|---|---|
| Novum | INDUSTRY |
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A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers.
This is an interventional, drug-drug interaction study to evaluate the effect of daily doses of Obicetrapib tablets on the pharmacokinetics of a combined oral contraceptive (COC), Drospirenone and Ethinyl Estradiol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC) | Experimental | Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet |
|
| Treatment B: Obicetrapib | Experimental | Obicetrapib 10 mg tablets (daily) |
|
| Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC) | Experimental | Drospirenone (3mg)/Ethinyl Estradiol tablets (0.02mg) tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obicetrapib | Drug | oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of COC | Plasma Cmax concentration of COC with and without Obicetrapib | Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12) |
| Area under the plasma concentration-time (AUC0-Ï„) curve for COC with and without coadministration with Obicetrapib | Plasma AUC0-Ï„ for COC with and without coadministration of Obicetrapib | Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kent A Swaine | Novum Pharmaceutical Research Services, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NOVUM | Las Vegas | Nevada | 89121 | United States |
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| ID | Term |
|---|---|
| D013607 | Tablets |
| C035144 | drospirenone |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
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Open-label, multiple-dose, fixed sequence, drug-drug interaction study.
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| Obicetrapib + Drospirenone / Ethinyl Estradiol (COC) | Drug | oral administration |
|
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| Drospirenone / Ethinyl Estradiol (COC) | Drug | oral administration |
|
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| 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 |