Food Effect Study of D-0502 Tablet in Healthy Volunteers

NCT ID: NCT03810625

Last Updated: 2019-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2019-04-17

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence AB

D-0502 Dose Patients will get D-0502 single agent once in the fasted state and once in the fed state.

Group Type: EXPERIMENTAL

D-0502

Intervention Type: DRUG

D-0502 oral tablets

Sequence BA

D-0502 Dose Patients will get D-0502 single agent once in the fed state and once in the fasted state.

Group Type: EXPERIMENTAL

D-0502

Intervention Type: DRUG

D-0502 oral tablets

Interventions

D-0502

D-0502 oral tablets

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

InventisBio Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance Daytona Beach Clinical Research Unit

Daytona Beach, Florida, United States

Countries

United States

Other Identifiers

IBIO-302

Identifier Type: -

Identifier Source: org_study_id