Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open label, randomized, balanced, single dose, two-treatment (fed vs. fasting), two-period, two-sequence crossover study of postmenopausal female healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence AB | Experimental | D-0502 Dose Patients will get D-0502 single agent once in the fasted state and once in the fed state. |
|
| Sequence BA | Experimental | D-0502 Dose Patients will get D-0502 single agent once in the fed state and once in the fasted state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-0502 | Drug | D-0502 oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic: area under the plasma concentration versus time curve (AUC) | AUC: area under the plasma concentration versus time curve for D-0502; Unit: nM*hr | Day 1 through 4, Day 7 through 11 |
| Pharmacokinetic: maximum plasma drug concentration (Cmax) | Cmax: maximum plasma drug concentration of D-0502; Unit: nM | Day 1 through 4, Day 7 through 11 |
| Pharmacokinetic: Time to reach the Cmax (Tmax) | Tmax: Time to reach the Cmax of D-0502; Unit: hr | Day 1 through 4, Day 7 through 11 |
| Pharmacokinetic: Apparent terminal half-life (t1/2) | t1/2: apparent terminal half-life of D-0502; Unit: hr | Day 1 through 4, Day 7 through 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Number of treatment-related adverse events as assessed by CTCAE v4.0 | 2 weeks |
Not provided
Inclusion Criteria:
Subjects must be medically documented as healthy and acceptable at physical examination.
Subjects must have a BMI between 18.0 and 32.0 kg/m2 and a body weight of 45 kg or higher.
Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator.
Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator.
Subjects must be female with postmenopausal status defined as meeting at least one of the following criteria:
Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Daytona Beach Clinical Research Unit | Daytona Beach | Florida | 32117 | United States |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |