Food Effect Study of D-0502 Tablet in Healthy Volunteers
Status: | Active, not recruiting |
---|---|
Conditions: | Breast Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/20/2019 |
Start Date: | October 18, 2018 |
End Date: | June 13, 2019 |
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
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.
two-period, two-sequence crossover study of postmenopausal female healthy subjects.
Inclusion Criteria:
1. Subjects must be medically documented as healthy and acceptable at physical
examination.
2. Subjects must have a BMI between 18.0 and 32.0 kg/m2 and a body weight of 45 kg or
higher.
3. Subjects must have all laboratory parameters within the normal range or considered not
clinically significant by the principal investigator.
4. Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically
significant by the principal investigator.
5. Subjects must be female with postmenopausal status defined as meeting at least one of
the following criteria:
1. Have undergone a bilateral oophorectomy any time in life;
2. Age ≥60 years, or
3. 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]).
6. Subjects are able to understand the study procedures and risks involved and must
provide signed informed consent to participate in the study.
Exclusion Criteria:
1. 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.
2. Subjects who have any history or suspicion of kidney stones.
3. Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B, and/or
Hepatitis C.
4. 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.
5. Subjects had undergone major surgery within 3 months prior to Day 1.
6. 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.
7. Subjects with positive urine drug screen test at screening.
8. 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.
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