Food Effect Study of D-0502 Tablet in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Phase I, Randomized, Open Label, Two-Sequence, Two-Period Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of D-0502 Tablet in Postmenopausal Female Healthy Subjects

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: D-0502


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Have undergone a bilateral oophorectomy any time in life; Age ≥60 years, or Age <60 years but have cessation of regular menses ≥12 months with follicle stimulating hormone (FSH) value >40 milli-international units per milliliter (mIU/mL) and an estradiol value <40 picograms per milliliter (pg/mL) (140 picomoles per liter [pmol/L]). Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study. Exclusion Criteria: Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological or psychiatric disorders, as determined by the investigator. Subjects who have any history or suspicion of kidney stones. Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B, and/or Hepatitis C. Subjects who have used prescription drugs, over-the-counter drugs, or natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days before Day 1 of study medication dosing. Subjects had undergone major surgery within 3 months prior to Day 1. Subjects who is participating in a clinical research study involving the administration of an investigational or marketed drug or device, or who received any investigational test article within 5 half-lives or 30 days prior to Day 1 study medication dosing. Subjects with positive urine drug screen test at screening. Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence AB<br>D-0502 Dose Patients will get D-0502 single agent once in the fasted state and once in the fed state. | Drug: D-0502<br>* D-0502 oral tablets<br>|
| Experimental: Sequence BA<br>D-0502 Dose Patients will get D-0502 single agent once in the fed state and once in the fasted state. | Drug: D-0502<br>* D-0502 oral tablets<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Number of treatment-related adverse events as assessed by CTCAE v4.0 | 2 weeks |