Food Effect Study of D-0502 Tablet in Healthy Volunteers

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: D-0502

• Registration Number: NCT03810625
• Lead Sponsor: InventisBio Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-23
• Primary Completion: 2018-11-21
• Study First Submitted: 2018-12-16
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-18
• Study Completion: 2019-04-17
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence AB	D-0502	D-0502 Dose Patients will get D-0502 single agent once in the fasted state and once in the fed state.
Sequence BA	D-0502	D-0502 Dose Patients will get D-0502 single agent once in the fed state and once in the fasted state.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic: area under the plasma concentration versus time curve (AUC)	Day 1 through 4, Day 7 through 11	AUC: area under the plasma concentration versus time curve for D-0502; Unit: nM\*hr
Pharmacokinetic: maximum plasma drug concentration (Cmax)	Day 1 through 4, Day 7 through 11	Cmax: maximum plasma drug concentration of D-0502; Unit: nM
Pharmacokinetic: Time to reach the Cmax (Tmax)	Day 1 through 4, Day 7 through 11	Tmax: Time to reach the Cmax of D-0502; Unit: hr
Pharmacokinetic: Apparent terminal half-life (t1/2)	Day 1 through 4, Day 7 through 11	t1/2: apparent terminal half-life of D-0502; Unit: hr

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	2 weeks	Number of treatment-related adverse events as assessed by CTCAE v4.0

Trial Locations

Locations (1)

Covance Daytona Beach Clinical Research Unit; 🇺🇸 Daytona Beach, Florida, United States