Trial Outcomes & Findings for Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants (NCT NCT01639222)

Results Overview

Ca2+ Ae0-6h was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

55 participants

Primary outcome timeframe

Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose

Results posted on

2013-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	Calcium 500 mg and Vitamin D3 800 IU Period 1: Low calcium meals for up to 3 days. Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals.
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Calcium 500 mg and Vitamin D3 800 IU n=55 Participants Period 1: Low calcium meals for up to 3 days. Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals.
Age Continuous	57.07 Years STANDARD_DEVIATION 7.01 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Region of Enrollment Germany	55 Participants n=5 Participants
Height	172.71 cm STANDARD_DEVIATION 8.97 • n=5 Participants
Weight	77.28 kg STANDARD_DEVIATION 10.06 • n=5 Participants
Body Mass Index (BMI)	25.87 kg/m² STANDARD_DEVIATION 2.33 • n=5 Participants
Creatinine Clearance	86.60 mL/min/1.73 m² STANDARD_DEVIATION 14.85 • n=5 Participants

PRIMARY outcome

Timeframe: Day 3 of Period 1 (Reference) and Day 3 in Period 2. Samples were taken 0-6 Hours post dose

Population: The Pharmacokinetic/Pharmacodynamic (PK/PD) Set included all enrolled subjects who received at least one dose of the mock treatment who had reliable values of either the primary PK parameter Ca2+ Ae0-6h in both periods or the primary PD parameter PTH AUC0-6h in both periods.

Ca2+ Ae0-6h was calculated as the urine volume of the urine collected from 0 to 6 hours multiplied by the calcium concentration measured in urine.

Outcome measures

Outcome measures
Measure	Calcium 500 mg and Vitamin D3 800 IU n=55 Participants Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.	Reference Treatment n=55 Participants Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)	1.07 mmol Standard Deviation 0.49	0.63 mmol Standard Deviation 0.43

PRIMARY outcome

Timeframe: Day 3 in Period 1 (Reference) and Day 3 in Period 2. Samples were taken at predose, 0.5, 1, 2, 3, 4, and 6 hour post dose.

Population: PK/PD set

The area under the curve from 0 to 6 hours post dose of parathyroid hormone (PTH AUC0-6h) in serum, calculated using the linear trapezoidal formula.

Outcome measures

Outcome measures
Measure	Calcium 500 mg and Vitamin D3 800 IU n=55 Participants Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.	Reference Treatment n=55 Participants Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum	202.02 h*pg/mL Standard Deviation 63.51	278.86 h*pg/mL Standard Deviation 79.71

SECONDARY outcome

Timeframe: Day 3 of Period 1 (Baseline) and Day 3 in Period 2. Samples will be taken 0-6 Hours postdose

Population: PK/PD set

To account for potential inaccuracies in urine collection, creatinine correction of calcium excretion was also assessed. Ca2+ Ae0-6h/Creatinine was obtained by dividing the urinary concentration of calcium by the urinary creatinine concentration.

Outcome measures

Outcome measures
Measure	Calcium 500 mg and Vitamin D3 800 IU n=55 Participants Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.	Reference Treatment n=55 Participants Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)	1.05 liters Standard Deviation 0.92	0.69 liters Standard Deviation 0.59

Adverse Events

Calcium 500 mg and Vitamin D3 800 IU

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Reference Treatment

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Calcium 500 mg and Vitamin D3 800 IU n=55 participants at risk Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.	Reference Treatment n=55 participants at risk Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
Nervous system disorders Headache	1.8% 1/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.	5.5% 3/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.
Nervous system disorders Dizziness	1.8% 1/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.	0.00% 0/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.
Gastrointestinal disorders Diarrhoea	5.5% 3/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.	0.00% 0/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.
Gastrointestinal disorders Constipation	0.00% 0/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.	1.8% 1/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.
Investigations Blood pressure increased	0.00% 0/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.	1.8% 1/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.	1.8% 1/55 • Up to 13 days. 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. A safety follow-up phone call was conducted 7 to 12 days after last dosing.

Additional Information

Sr. VP, Clinical Science

Takeda Global Research and Development Center, Inc.

Phone: 800-778-2860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights therefrom or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER