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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1163-1751 | Registry Identifier | WHO | |
| 2014-003875-53 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcichew D3 | Drug | Calcium 500 mg and vitamin D3 1000 IU chewable tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes | France |
Healthy participants were enrolled in this study. Treatment period of study comprised of 2-periods. Participants received noncarbonated water in period 1 (dummy treatment period) and Calcichew D3 in period 2 (study treatment period).
Participants took part in the study at 1 investigative site in France from 16 January 2015 to 24 February 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Noncarbonated Water+Calcichew D3 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The safety analysis set included all participants who were enrolled and received at least 1 dose of dummy treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Noncarbonated Water+Calcichew D3 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Pharmacodynamic(PD) serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of parathyroid hormone in each treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*picogram per milliliter (hr*pg/mL) | 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 |
|
Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 14 days after the last dose of Calcichew D3 study drug (21 days).
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Noncarbonated Water | Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| Noncarbonated Water | Drug | Noncarbonated water 200 mL |
|
| (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. | 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 | 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 | 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 | 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 | 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) | Baseline up to 14 days after last dose of study drug (Day 21) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
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| Weight | Mean | Standard Deviation | kilogram (kg) |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
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| Smoking classification | Number | participants |
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| Alcohol classification | Number | participants |
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| Xanthine/Caffeine Consumption | Number | participants |
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| Number of Participants who were Postmenopausal | Number | participants |
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| OG001 | Calcichew D3 | Calcichew D3 500 mg/1000 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). |
|
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| Primary | (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. | The pharmacokinetic(PK) urine analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable urine concentration of calcium in each treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | millimoles (mmol) | 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 |
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|
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| Secondary | 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. | The PD serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of parathyroid hormone in each treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*pg/mL | 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 |
|
|
|
| Secondary | (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. | The PK urine analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable urine concentration of calcium in each treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | mmol | 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 |
|
|
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| Secondary | Cmax: Maximum Observed Serum Concentration for Calcium | The PK serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | millimoles per litre(mmol/L) | 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 |
|
|
|
| Secondary | AUC(0-6): Area Under the Serum Concentration-Time Curve From Time 0 to 6 Hours for Calcium | The PK serum analysis set included all participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*millimoles per litre (hr*mmol/L) | 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 |
|
|
|
| Secondary | AUC(0-24): Area Under the Serum Concentration-Time Curve From Time 0 to 24 Hours Post-dose for Calcium | The PK serum analysis set of included participants who received at least 1 dose of dummy treatment and had at least 1 measurable serum concentration of calcium in each treatment period. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*mmol/L | 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 |
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| Secondary | Tmax: Time to Reach the Cmax for Calcium | The PK analysis set consisted of all participants who received at least 1 dose of dummy treatment and who had at least 1 measurable serum concentration of calcium in each treatment period. | Posted | Median | Full Range | hours | 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 |
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| Secondary | Number of Participants Who Experience at Least 1 Treatment-Emergent Adverse Event (TEAE) | The safety analysis set included all participants who were enrolled and received at least 1 dose of dummy treatment. | Posted | Number | participants | Baseline up to 14 days after last dose of study drug (Day 21) |
|
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|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Calcichew D3 | Calcichew D3 500 mg/1000 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). | 0 | 27 | 2 | 27 |
No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.