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The main purpose of this study is to determine the effect of vimseltinib on pharmacokinetics of combined oral contraceptive (COC) (ethinyl estradiol/levonorgestrel) in healthy female participants. This study will last approximately 35 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vimseltinib + Combined Oral Contraceptive (COC) | Experimental | Day 1 single dose of combined oral contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG]). Day 4 through 7, Day 11 and Day 14 single daily dose of Vimseltinib. Day 18 coadministration of COC (EE /LNG) with vimseltinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vimseltinib | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Plasma Drug Concentration (Cmax) of EE and LNG | Predose up to 72 Hours Post Dose | |
| PK: Area Under the Plasma Concentration-Time Curve from Time 0 up to Time t (AUC0-t), Where t is the Last Time Point at which the Concentration is Above the Lower Limit of Quantification, of EE and LNG | Predose up to 72 Hours Post Dose | |
| PK: AUC from Time 0 to Infinity (AUC0-∞) of EE and LNG | Predose up to 72 Hours Post Dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Apparent Systemic Clearance (CL/F) of EE and LNG | Predose up to 72 Hours Post Dose | |
| PK: Apparent Volume of Distribution Associated with the Terminal Phase (Vz/F) of EE and LNG | Predose up to 72 Hours Post Dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Team | Contact | 888-724-3274 | clinicaltrials@deciphera.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Team | Deciphera Pharmaceuticals, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network | Recruiting | Saint Paul | Minnesota | 55114 | United States |
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| Combined Oral Contraceptive (COC) (ethinyl estradiol [EE]/levonorgestrel [LNG]) |
| Drug |
Administered orally |
|
| PK: Time to Maximum Observed Plasma Concentration (Tmax) of EE and LNG | Predose up to 72 Hours Post Dose |
| PK: Terminal Elimination Phase Half-Life (t1/2) of EE and LNG | Predose up to 72 Hours Post Dose |
| Safety: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Baseline through Day 35 |
| Safety: Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters | Baseline through Day 21 |
| Safety: Number of Participants with Clinically Significant Change from Baseline in Vital Signs | Baseline through Day 21 |
| ID | Term |
|---|---|
| D003277 | Contraceptives, Oral, Combined |
| D004997 | Ethinyl Estradiol |
| ID | Term |
|---|---|
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003276 | Contraceptives, Oral |
| 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 |
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