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

NCT03660800 | Completed Phase 1 FDA Drug

• 1 other identifier: CTAP101-CL-1020
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin D Insufficiency; Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (3)

• Number of participants with treatment-related AEs as assessed by industry standards

  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

  Baseline finding will be measured against the different time points collected

  8 weeks

• Change in mean total of the different components of calcifediol

  Descriptive statistics will be calculated for PD assessment in the per protocol population.

  8 weeks

Study Arms (4)

CTAP101 Capsules 450mcg/weekly fasted

EXPERIMENTAL

Drug: CTAP101 Capsules

CTAP101 Capsules 900mcg/weekly fasted

EXPERIMENTAL

Drug: CTAP101 Capsules

CTAP101 Capsules 1800mcg/weekly fasted

EXPERIMENTAL

Drug: CTAP101 Capsules

CTAP101 Capsules 900mcg/weekly fed

EXPERIMENTAL

Drug: CTAP101 Capsules

Interventions

CTAP101 Capsules DRUG

Calcifediol Extended-Release Capsules

CTAP101 Capsules 1800mcg/weekly fasted; CTAP101 Capsules 450mcg/weekly fasted; CTAP101 Capsules 900mcg/weekly fasted; CTAP101 Capsules 900mcg/weekly fed

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (1)

WCCT Global, Inc.

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Jeremy Mussallem

  WCCT Global, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 7, 2018
• Study Start: August 20, 2018
• Primary Completion: October 24, 2018
• Study Completion: January 22, 2019
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)