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Vitamin D InsufficiencyPhase 1NCT03660800

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

A Phase 1 study testing CTAP101 Capsules in people with Vitamin D Insufficiency and Secondary Hyperparathyroidism, run by OPKO Health, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pharmacokinetics and Safety Study of CTAP101 Capsules in Japanese and non-Japanese Healthy Subjects Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
CTAP101 Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteUnited States
Study dates
20 Aug 2018to 22 Jan 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • WCCT Global, Inc.

    Cypress, California, 90630

Other trials in United States

About this study

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

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

Read the 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

Being tested
CTAP101 Capsules
Medical subject headings
Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTAP101 CapsulesDrug

    Calcifediol Extended-Release Capsules

Study groups in NCT03660800
Study groupRoleWhat they receive
CTAP101 Capsules 450mcg/weekly fastedExperimentalNot described
Receives: Drug: CTAP101 Capsules
CTAP101 Capsules 900mcg/weekly fastedExperimentalNot described
Receives: Drug: CTAP101 Capsules
CTAP101 Capsules 1800mcg/weekly fastedExperimentalNot described
Receives: Drug: CTAP101 Capsules
CTAP101 Capsules 900mcg/weekly fedExperimentalNot described
Receives: Drug: CTAP101 Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

  2. Change in baseline of peak plasma concentration

    Baseline finding will be measured against the different time points collected

    Measured: 8 weeks

  3. Change in mean total of the different components of calcifediol

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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2018
  2. Study start20 Aug 2018
  3. Primary completion24 Oct 2018
  4. Study completion22 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03660800
Sponsor's protocol ID
CTAP101-CL-1020
Status last verified
Sep 2019
First submitted
23 Aug 2018
Last updated
30 Sep 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CTAP101 Capsules in people with Vitamin D Insufficiency and Secondary Hyperparathyroidism, run by OPKO Health, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related AEs as assessed by industry standards (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03660800.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.

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