Food Effect Study of D-0502 Tablet in Healthy Volunteers

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810625
• Other study ID #: IBIO-302
• Status: Completed
• Phase: Phase 1
• Start date: October 23, 2018
• Est. completion date: April 17, 2019

Study information

• Verified date: August 2019
• Source: InventisBio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 17, 2019
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• D-0502
D-0502 oral tablets

Locations

Country	Name	City	State
United States	Covance Daytona Beach Clinical Research Unit	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
InventisBio Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pharmacokinetic: maximum plasma drug concentration (Cmax)	Cmax: maximum plasma drug concentration of D-0502; Unit: nM	Day 1 through 4, Day 7 through 11
Primary	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
Primary	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	Incidence of Treatment-Emergent Adverse Events	Number of treatment-related adverse events as assessed by CTCAE v4.0	2 weeks