- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03660800
Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and Non-Japanese Healthy Subjects and Non-Japanese Healthy Subjects
An Open-label, Single-Dose, Safety, Tolerability and Pharmacokinetic Study of Oral CTAP101 (Calcifediol) Extended-release Capsules in Japanese and Non-Japanese Healthy Subjects
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Cypress, California, United States, 90630
- WCCT Global, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
- 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
- Willing and able to comply with study instructions and to commit to all study days
- Man or woman, 18 to 55 years of age inclusive at the time of signing the informed consent form
- Overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests
- Body mass index (BMI) within 18.0 to 30.0 kg/m2 (inclusive) and body weight not less than 50 kg
- Blood pressure (after at least 2 minutes of rest) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic.
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
- Must have negative tests for drugs of abuse at Screening and Day -2
- Must have a negative alcohol test at Screening and Day -2
- Must have adequate venous access in both arms, in the opinion of the Investigator
- Has a screening serum total 25-hydroxyvitamin D level between 10 and 40 ng/mL, inclusive
- 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
- 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
- Not of Japanese or Asian descent
- 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:
- Has taken a Vitamin D supplement within 28 days prior to dosing
- Has a medically confirmed history of kidney stones within the previous 2 years
- Has a urine calcium: creatinine ratio > 0.2 at the Screening visit
- Has a known or suspected hypersensitivity to any of the constituents of the investigational products
- 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.
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
- Clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening as deemed appropriate by the investigator
- 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.
- 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.
- Has donated 1 unit (450 mL) or more of blood or plasma within 30 days of dosing
- Has an acute illness within 5 days prior to the first dose of study medication
- 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).
- 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
- 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
- Is considering or has preplanned surgery or procedures that would interfere with the conduct of the study
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CTAP101 Capsules 450mcg/weekly fasted
|
Calcifediol Extended-Release Capsules
|
EXPERIMENTAL: CTAP101 Capsules 900mcg/weekly fasted
|
Calcifediol Extended-Release Capsules
|
EXPERIMENTAL: CTAP101 Capsules 1800mcg/weekly fasted
|
Calcifediol Extended-Release Capsules
|
EXPERIMENTAL: CTAP101 Capsules 900mcg/weekly fed
|
Calcifediol Extended-Release Capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
Change in baseline of peak plasma concentration
Time Frame: 8 weeks
|
Baseline finding will be measured against the different time points collected
|
8 weeks
|
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.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jeremy Mussallem, WCCT Global, Inc
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTAP101-CL-1020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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