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Food Effect Study of D-0502 Tablet in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03810625
Recruitment Status : Active, not recruiting
First Posted : January 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
InventisBio Inc.

Tracking Information
First Submitted Date  ICMJE December 16, 2018
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE October 18, 2018
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03810625 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 weeks ]
Number of treatment-related adverse events as assessed by CTCAE v4.0
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
Incidence of Treatment-Emergent Adverse Events [ Time Frame: 2 weeks ]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Food Effect Study of D-0502 Tablet in Healthy Volunteers
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: D-0502
D-0502 oral tablets
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 17, 2019)
14
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2019
Actual Primary Completion Date January 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810625
Other Study ID Numbers  ICMJE IBIO-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InventisBio Inc.
Study Sponsor  ICMJE InventisBio Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InventisBio Inc.
Verification Date April 2019

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