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

NCT ID: NCT03660800

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-20
• Study Completion Date: 2019-01-22

Brief Summary

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

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

Conditions

Vitamin D Insufficiency; Secondary Hyperparathyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CTAP101 Capsules 450mcg/weekly fasted

Group Type: EXPERIMENTAL

CTAP101 Capsules

Intervention Type: DRUG

Calcifediol Extended-Release Capsules

CTAP101 Capsules 900mcg/weekly fasted

Group Type: EXPERIMENTAL

CTAP101 Capsules

Intervention Type: DRUG

Calcifediol Extended-Release Capsules

CTAP101 Capsules 1800mcg/weekly fasted

Group Type: EXPERIMENTAL

CTAP101 Capsules

Intervention Type: DRUG

Calcifediol Extended-Release Capsules

CTAP101 Capsules 900mcg/weekly fed

Group Type: EXPERIMENTAL

CTAP101 Capsules

Intervention Type: DRUG

Calcifediol Extended-Release Capsules

Interventions

CTAP101 Capsules

Calcifediol Extended-Release Capsules

Intervention Type: DRUG

Eligibility 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

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

OPKO Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy Mussallem

Role: STUDY_CHAIR

WCCT Global, Inc

Locations

WCCT Global, Inc.

Cypress, California, United States

Countries

United States

Other Identifiers

CTAP101-CL-1020

Identifier Type: -

Identifier Source: org_study_id