Healthy VolunteersPhase 1NCT02338713
Effect of Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet on Intestinal Calcium Absorption
A Phase 1 study testing Calcichew D3 and Noncarbonated Water in people with Healthy Volunteers, run by Takeda at 1 site in France.
Trial summary
The purpose of this study is to demonstrate that the intestinal absorption of calcium from a novel calcium carbonate-vitamin D3 chewable tablet formulation (calcium 500 milligrams (mg) and vitamin D3 1000 International Units (IU)) increases the amount of calcium excreted in urine and decreases parathyroid hormone… Read more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Calcichew D3 and Noncarbonated Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Feb 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
- Is a healthy adult male or female participant.
- Female participants should be postmenopausal (last menses at least 2 years before signing informed consent and follicle-stimulating hormone (FSH) confirming postmenopausal status).
- The participant is White.
- Is aged 45 to 70 years, inclusive, at the time of informed consent and study enrollment.
- Weighs at least 50 kg and has a body mass index (BMI) from 18 to 30 kilogram per square meter (kg/m^2), inclusive at Screening and Day -1.
- Is a nonsmoker (having abstained from smoking for at least 6 months).
Who cannot join
- Has received any investigational compound within 30 days prior to Screening.
- Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
- Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
- Has a known hypersensitivity to calcium or vitamin D3 or to any of the excipients of the formulation of the Calcichew D3 chewable tablet.
- Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in (Day -1).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular consumption of 5 or more units per day) within 5 years prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study. One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine. Ethanol consumption within 72 hours prior to Check-in (Day -1) verified by alcohol breath test (Alcotest).
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- Has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table.
- Has current or recent (within 6 months) gastrointestinal disorder or gastrointestinal surgery (except appendectomy) that would be expected to influence the absorption of drugs and calcium (ie, a history of malabsorption, esophageal reflux, peptic ulcer disease, erosive esophagitis, frequent [more than once per week] occurrence of heartburn, or any surgical intervention [eg, cholecystectomy]).
- Has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years prior to Day 1.
- Has a positive test result for hepatitis B surface antigen (HBsAg), antibody to hepatitis C virus (anti-HCV), and human immunodeficiency virus (HIV) antibody at Screening.
- Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 21 days prior to Check-in (Day -1). Cotinine test is positive at Screening or Check-in (Day -1).
- Has poor peripheral venous access.
- Has donated or lost 450 millileters (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day 1.
- Has a Screening or Check-in (Day -1) abnormal (clinically significant) electrocardiogram (ECG). Entry of any participant with an abnormal (not clinically significant) ECG must be approved, and documented by signature by both the principal investigator and the Takeda medical monitor.
- Has abnormal Screening or Day -1 laboratory values that suggest a clinically significant underlying disease or participant with the following laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than (>)2.0 times the upper limit of normal (ULN).
- Is a practicing vegetarian or vegan.
- Has a creatinine clearance according to Modification of Diet in Renal Disease equation of less than (<)60 mL/min at Screening or Check-in (Day -1).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Sequence, 2-Period, Open-Label Study of a Novel Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet Dosed for 3 Days to Investigate the Effect on Intestinal Calcium Absorption in Healthy Postmenopausal Women and Healthy Men
The purpose of this study is to demonstrate that the intestinal absorption of calcium from a novel calcium carbonate-vitamin D3 chewable tablet formulation (calcium 500 milligrams (mg) and vitamin D3 1000 International Units (IU)) increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared with Baseline.
Read the detailed description
The drug being tested in this study was called Calcichew D3. Calcichew D3 was being tested to assess how it is processed by the body in healthy men and postmenopausal women. This study looked at lab results in people who take Calcichew D3.
The study enrolled approximately 27 participants. All participants received the same treatment:
- Calcichew D3 (calcium 500 mg and vitamin D3 1000 IU) chewable tablets All participants were asked to take one tablet each morning of the treatment period.
This single-centre trial was conducted in France. The overall time to participate in this study was up to 44 days. Participants made 2 visits to the clinic, including one 7-day period of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
- Conditions
- Healthy Volunteers
- Being tested
- Calcichew D3, Noncarbonated Water
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcichew D3Drug
Calcium 500 mg and vitamin D3 1000 IU chewable tablets
Noncarbonated WaterDrug
Noncarbonated water 200 mL
| Study group | Role | What they receive |
|---|---|---|
| Noncarbonated Water + Calcichew D3 | Experimental | Noncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period. Receives: Drug: Calcichew D3; Drug: Noncarbonated Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTH AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Parathyroid Hormone
The PTH AUC(0-6) is a measure of the area under the serum concentration-time curve from 0 to 6 hours of parathyroid hormone.
Measured: Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group
(Ca^2+ Ae6): Amount of Calcium Excreted in Urine From Time 0 to 6 Hours Post-dose
Ca^2+ Ae6 was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.
Measured: Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group
Secondary outcomes (7)
PTH AUC (0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours for Parathyroid Hormone
The PTH AUC(0-24) is a measure of the area under the serum concentration-time curve from 0 to 24 hours of parathyroid hormone.
Measured: Days 3 and 6: pre-dose and at multiple time-points (up to 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the calcichew D3 reporting group
(Ca^2+ Ae24): Amount of Calcium Excreted in Urine From Time 0 to 24 Hours Post-dose
Ca2+ Ae0-24 was calculated as the urine volume of the urine collected from 0 to 24 hours multiplied by the calcium concentration measured in urine.
Measured: Days 3 and 6: pre-dose and at multiple time-points (upto 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group
Cmax: Maximum Observed Serum Concentration for Calcium
Measured: Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group
AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Calcium
Measured: Days 3 and 6: predose and at multiple time-points (up to 6 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group
AUC(0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Calcium
Measured: Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group
Tmax: Time to Reach the Cmax for Calcium
Measured: Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group
Number of Participants Who Experience at Least 1 Treatment-Emergent Adverse Event (TEAE)
Measured: Baseline up to 14 days after last dose of study drug (Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338713
- Sponsor's protocol ID
- Calcichew-1001
- Other IDs
- U1111-1163-1751, 2014-003875-53, 2014
- Status last verified
- Apr 2017
- First submitted
- 18 Dec 2014
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Sequence, 2-Period, Open-Label Study of a Novel Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet Dosed for 3 Days to Investigate the Effect on Intestinal Calcium Absorption in Healthy Postmenopausal Women and Healthy Men
- ClinicalTrials.gov ID
- NCT02338713
- Acronym / sponsor ID
- Calcichew-1001
- Conditions
- Healthy Volunteers
- Keywords
- Drug therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 14 Jan 2015 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that the intestinal absorption of calcium from a novel calcium carbonate-vitamin D3 chewable tablet formulation (calcium 500 milligrams (mg) and vitamin D3 1000 International Units (IU)) increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared with Baseline.
Detailed description
The drug being tested in this study was called Calcichew D3. Calcichew D3 was being tested to assess how it is processed by the body in healthy men and postmenopausal women. This study looked at lab results in people who take Calcichew D3.
The study enrolled approximately 27 participants. All participants received the same treatment:
- Calcichew D3 (calcium 500 mg and vitamin D3 1000 IU) chewable tablets All participants were asked to take one tablet each morning of the treatment period.
This single-centre trial was conducted in France. The overall time to participate in this study was up to 44 days. Participants made 2 visits to the clinic, including one 7-day period of confinement to the clinic, and were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Noncarbonated Water + Calcichew D3 | Experimental | Drug: Calcichew D3, Drug: Noncarbonated WaterNoncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures including requesting that a participant fast for any laboratory evaluations.
- Is a healthy adult male or female participant.
- Female participants should be postmenopausal (last menses at least 2 years before signing informed consent and follicle-stimulating hormone (FSH) confirming postmenopausal status).
- The participant is White.
Key exclusion criteria (17 listed)
- Has received any investigational compound within 30 days prior to Screening.
- Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (example, spouse, parent, child, sibling) or may consent under duress.
- Has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
- Has a known hypersensitivity to calcium or vitamin D3 or to any of the excipients of the formulation of the Calcichew D3 chewable tablet.
- Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in (Day -1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcichew D3Calcium 500 mg and vitamin D3 1000 IU chewable tablets | Drug | Noncarbonated Water + Calcichew D3 |
| Noncarbonated WaterNoncarbonated water 200 mL | Drug | Noncarbonated Water + Calcichew D3 |
Primary outcome
PTH AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Parathyroid Hormone
Time frame: Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group
The PTH AUC(0-6) is a measure of the area under the serum concentration-time curve from 0 to 6 hours of parathyroid hormone.
(Ca^2+ Ae6): Amount of Calcium Excreted in Urine From Time 0 to 6 Hours Post-dose
Time frame: Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group
Ca^2+ Ae6 was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.
7 secondary outcomes
PTH AUC (0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours for Parathyroid Hormone
Time frame: Days 3 and 6: pre-dose and at multiple time-points (up to 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the calcichew D3 reporting group
(Ca^2+ Ae24): Amount of Calcium Excreted in Urine From Time 0 to 24 Hours Post-dose
Time frame: Days 3 and 6: pre-dose and at multiple time-points (upto 24 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group
Cmax: Maximum Observed Serum Concentration for Calcium
Time frame: Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group
AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Calcium
Time frame: Days 3 and 6: predose and at multiple time-points (up to 6 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group
AUC(0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Calcium
Time frame: Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group
Tmax: Time to Reach the Cmax for Calcium
Time frame: Days 3 and 6: predose and at multiple time-points (up to 24 hours) postdose. Day 3 for the non carbonated water reporting group and Day 6 for the Calcichew D3 reporting group
Number of Participants Who Experience at Least 1 Treatment-Emergent Adverse Event (TEAE)
Time frame: Baseline up to 14 days after last dose of study drug (Day 21)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Calcichew D3 and Noncarbonated Water in people with Healthy Volunteers, run by Takeda at 1 site in France.
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 8 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 16 Jun 2017. 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 France. 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?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PTH AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Parathyroid Hormone (time frame: Days 3 and 6: pre-dose and at multiple time-points (upto 6 hours) postdose. Day 3 for the noncarbonated water reporting group and Day 6 for the Calcichew D3 reporting group). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2017.