Food Effect Study of D-0502 Tablet in Healthy Volunteers

NCT03810625 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IBIO-302
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  2 weeks

Study Arms (2)

Sequence AB

EXPERIMENTAL

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

Drug: D-0502

Sequence BA

EXPERIMENTAL

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

Drug: D-0502

Interventions

D-0502 DRUG

D-0502 oral tablets

Sequence AB; Sequence BA

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

Covance Daytona Beach Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2018
• First Posted: January 18, 2019
• Study Start: October 23, 2018
• Primary Completion: November 21, 2018
• Study Completion: April 17, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

US (1)