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Food Effect Study of D-0502 Tablet in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03810625
Recruitment Status : Active, not recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
InventisBio Inc.

December 16, 2018
January 18, 2019
January 18, 2019
October 18, 2018
January 30, 2019   (Final data collection date for primary outcome measure)
  • Pharmacokinetic: area under the plasma concentration versus time curve (AUC) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Day 1 through 4, Day 7 through 11 ]
    t1/2: apparent terminal half-life of D-0502; Unit: hr
Same as current
No Changes Posted
Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 weeks ]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Same as current
Not Provided
Not Provided
 
Food Effect Study of D-0502 Tablet in Healthy Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: D-0502
D-0502 oral tablets
  • Experimental: Sequence AB
    D-0502 Dose Patients will get D-0502 single agent once in the fasted state and once in the fed state.
    Intervention: Drug: D-0502
  • Experimental: Sequence BA
    D-0502 Dose Patients will get D-0502 single agent once in the fed state and once in the fasted state.
    Intervention: Drug: D-0502
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
14
Same as current
June 13, 2019
January 30, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03810625
IBIO-302
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
InventisBio Inc.
InventisBio Inc.
Not Provided
Not Provided
InventisBio Inc.
December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP