Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Healthy Subjects

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: NCT03660800
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
OPKO Health, Inc.

Brief Summary:
Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and non-Japanese Healthy Subjects

Condition or disease Intervention/treatment Phase
Vitamin D Insufficiency Secondary Hyperparathyroidism Drug: CTAP101 Capsules Phase 1

Detailed Description:
An Open-label, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of Oral CTAP101 (Calcifediol) Extended-release Capsules in Japanese and non-Japanese Healthy Subjects

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-label, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of Oral CTAP101 (Calcifediol) Extended-release Capsules in Japanese and Non-Japanese Healthy Subjects
Actual Study Start Date : August 20, 2018
Actual Primary Completion Date : October 24, 2018
Actual Study Completion Date : January 22, 2019

Arm Intervention/treatment
Experimental: CTAP101 Capsules 450mcg/weekly fasted Drug: CTAP101 Capsules
Calcifediol Extended-Release Capsules

Experimental: CTAP101 Capsules 900mcg/weekly fasted Drug: CTAP101 Capsules
Calcifediol Extended-Release Capsules

Experimental: CTAP101 Capsules 1800mcg/weekly fasted Drug: CTAP101 Capsules
Calcifediol Extended-Release Capsules

Experimental: CTAP101 Capsules 900mcg/weekly fed Drug: CTAP101 Capsules
Calcifediol Extended-Release Capsules




Primary Outcome Measures :
  1. Number of participants with treatment-related AEs as assessed by industry standards [ Time Frame: 8 weeks ]
    Incidence of AEs will be summarized by arm for all treatment-emergent AEs. Number and percent of participants with AEs will be summarized by system organ class and preferred term and presented overall and by arm.

  2. Change in baseline of peak plasma concentration [ Time Frame: 8 weeks ]
    Baseline finding will be measured against the different time points collected

  3. Change in mean total of the different components of calcifediol [ Time Frame: 8 weeks ]
    Descriptive statistics will be calculated for PD assessment in the per protocol population.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Participants are eligible to be included in the study only if all of the following criteria apply:

  1. Signed the informed consent form as described in Appendix 3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
  2. Willing and able to comply with study instructions and to commit to all study days
  3. Man or woman, 18 to 55 years of age inclusive at the time of signing the informed consent form
  4. Overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests
  5. Body mass index (BMI) within 18.0 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
  6. Blood pressure (after at least 2 minutes of rest) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
  7. A 12-lead ECG consistent with normal cardiac conduction and function, including:

    • Sinus rhythm
    • Pulse rate between 40 and 100 beats per minute (bpm)
    • QTc interval ≤450 milliseconds (QT interval corrected using Fridericia correction method [QTcF]
    • QRS interval of <120 milliseconds
    • PR interval <200 milliseconds
    • Morphology consistent with healthy cardiac conduction and function
  8. Must have negative tests for drugs of abuse at Screening and Day -2
  9. Must have a negative alcohol test at Screening and Day -2
  10. Must have adequate venous access in both arms, in the opinion of the Investigator
  11. Has a screening serum total 25-hydroxyvitamin D level between 10 and 40 ng/mL, inclusive
  12. If male, must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period
  13. If female, be sterile (ie, at least 1 month post-surgical sterilization, confirmed nonsurgical sterilization or at least 6 months post-menopausal [as determined by follicle stimulating hormone (FSH) / estradiol testing]); or who are of childbearing potential but are abstinent, have a surgically sterile partner (ie, at least 6 months postvasectomy), or are using a copper intrauterine device or a combination of at least 2 acceptable barrier methods such as condom + intravaginal spermicide, diaphragm + intravaginal spermicide, or cervical cap + intravaginal spermicide. Contraceptive medications (oral or by other routes) containing steroid hormones are not allowed. Women of childbearing potential must not be lactating and must have a negative pregnancy test at screening and Day -2, and agree to continue their accepted method of contraception throughout the study. See guidance on contraceptives in Appendix 5. Additional Inclusion Criteria for Japanese Participants Only

1. Be first generation Japanese defined as:

  • Born in Japan
  • Has 2 Japanese biological parents and 4 Japanese biological grandparents
  • Has lived outside of Japan for less than 5 years
  • Has made no significant changes in lifestyle, including diet, since leaving Japan Additional Inclusion Criteria for non-Japanese Participants Only

    1. Not of Japanese or Asian descent
    2. Parents and grandparents not born in Japan or in any Asian countries Note: Retesting of abnormal lab values that may lead to exclusion will be allowed once.

Retesting will take place during an unscheduled visit during the screening phase.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  1. Has taken a Vitamin D supplement within 28 days prior to dosing
  2. Has a medically confirmed history of kidney stones within the previous 2 years
  3. Has a urine calcium: creatinine ratio > 0.2 at the Screening visit
  4. Has a known or suspected hypersensitivity to any of the constituents of the investigational products
  5. Has a history of or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); lipid abnormalities; significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal insufficiency (creatinine clearance below 60 mL/min); thyroid disease; neurologic or psychiatric disease; infection; or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
  6. Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
  7. Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening as deemed appropriate by the investigator
  8. Has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
  9. Has received an investigational drug or used an invasive investigational medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before Day 1.
  10. Has donated 1 unit (450 mL) or more of blood or plasma within 30 days of dosing
  11. Has an acute illness within 5 days prior to the first dose of study medication
  12. Has received any prescribed systemic or topical medication within 14 days of dosing, received a vaccination within 30 days of dosing, or taken any nonprescription systemic or topical medication or herbal preparation within 7 days of dosing (exception: occasional use of acetaminophen or ibuprofen at nonprescription doses).
  13. History of drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) criteria within 5 years before Screening or positive test result(s) for alcohol and/or drugs of abuse (including prescription drugs such as stimulants, opioids, and benzodiazepines) at Screening or at Admission on Day -2
  14. Has an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level >1.5 times the upper limit of normal (ULN), active liver disease or jaundice at Screening or Day -2
  15. Is considering or has preplanned surgery or procedures that would interfere with the conduct of the study
  16. Is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660800


Locations
Layout table for location information
United States, California
WCCT Global, Inc.
Cypress, California, United States, 90630
Sponsors and Collaborators
OPKO Health, Inc.
Investigators
Layout table for investigator information
Study Chair: Jeremy Mussallem WCCT Global, Inc
Layout table for additonal information
Responsible Party: OPKO Health, Inc.
ClinicalTrials.gov Identifier: NCT03660800    
Other Study ID Numbers: CTAP101-CL-1020
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases