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

NCT01639222 | Completed Phase 1 Results

• 3 other identifiers: CW-2200-401-RD2011-005786-21U1111-1124-2328
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate that the intestinal absorption of calcium from a newly developed calcium carbonate-vitamin D3 chewable tablet formulation increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared to baseline.

Conditions

Calcium Deficiency; Vitamin D Deficiency

Keywords

Drug therapy; Increase in calcium urinary excretion and PTH decrease in serum

Outcome Measures

Primary Outcomes (2)

• Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)

  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.

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

• Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum

  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.

  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.

Secondary Outcomes (1)

• Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)

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

Study Arms (1)

Calcium 500 mg and Vitamin D3 800 IU

EXPERIMENTAL

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.

Drug: Calcium 500 mg and Vitamin D3 800 IU; Other: Low calcium meals

Interventions

Calcium 500 mg and Vitamin D3 800 IU DRUG

Calcium 500 mg and Vitamin D3 800 IU chewable tablets

Also known as: Calcichew-D3 forte 500 mg/800 IU

Calcium 500 mg and Vitamin D3 800 IU

Low calcium meals OTHER

A normal Western European diet with reduced calcium content (400 mg per day).

Calcium 500 mg and Vitamin D3 800 IU

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a healthy postmenopausal woman (last menses at least 2 years before signing informed consent and follicle stimulating hormone (FSH) confirming postmenopausal status) or a healthy male aged between 45 to 70 years inclusively
• Was informed both verbally and in writing about the objectives of the clinical trial, the methods, the anticipated benefits and potential risks and the discomfort to which she/he might be exposed, and had given written consent to participation in the trial prior to any trial-related procedure
• Is Caucasian
• Is assessed as healthy based on physical examination, medical history, clinical laboratory, electrocardiogram (ECG), vital signs
• Is a non-smoker (having abstained from smoking for at least 6 months)
• Has a body mass index of 19 to 29.4 kg/m\^2 (inclusively)

You may not qualify if:

• Has a history of clinically significant allergies or idiosyncrasies to calcium or vitamin D3, or any inactive ingredient(s) of these products
• Is a lactating or pregnant female participant
• Female participants: Has a positive pregnancy test in serum at screening and in urine on Day -1 Period 1
• Participant was previously enrolled into the current clinical trial
• Has participated in the active treatment phase of another clinical trial where a persisting pharmacodynamic (PD) effect of the IMP of that clinical trial cannot be excluded (e.g. patient is well into a treatment free safety follow-up phase); or 10 times the pharmacokinetic (PK) half-life, whatever is longer but 30 days as minimum prior to the start of the clinical trial
• Has been considered unable or unwilling to co-operate adequately, i.e. to follow clinical trial procedures and Investigator instructions adequately (e.g. language difficulties, etc.) or participant is anticipated not to be available for scheduled clinical trial visits/procedures
• Has a dependency situation (e.g. person is kept in detention, Investigator in the current clinical trial, or a first-degree relative of a clinical trial Investigator, or is employee at the clinical trial site)
• Has a hypersensitivity to soya or peanut
• Abuse of alcohol or drugs
• Has consumed ethanol within 48 hours prior to hospitalization verified by alcohol breath test (Alcotest®)
• Has a history or current disease which might influence the trial objectives (e.g., urinary tract infection, urination problems \[e.g., prostate hyperplasia\] or urinary incontinence, renal insufficiency, nephrolithiasis, sarcoidosis, osteoporosis, calcium deficiency, hyper- or hypoparathyroidism, hypercalciuria, hypercalcaemia, calcium lithiasis, hyperphosphataemia, hypervitaminosis D, phenylketonuria, diabetes mellitus
• Has creatinine clearance according to Modification of Diet in Renal Disease (MDRD) equation of \< 60 mL/min
• Has regular use of any medication. Treatment with biphosphonates in the past 5 years, amidorone in the past 6 months, calcium or fluoride supplements, diuretics, vitamin D preparations, estrogens or estrogen receptor modulators, enzyme inducing agents, teriparatide or parathyroid hormone (PTH(1-84)), bile sequestrants within 3 months before screening, and for all other drugs within 2 weeks before screening (or 6 times the half-life of the respective drug) whatever is longer
• Has use of ultraviolet radiation cabins or sunbath longer than 1 h from 1 week before Day 1 of Period 1 until the End of Trial examination
• Has an intake of milk and milk products, broccoli, dark-green vegetables, vegetables from the mustard green family, fatty fish, eggs, liver, and added salt within 7 days prior to hospitalisation

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Mannheim, Baden-Wurttemberg, Germany

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Calcium; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Sr. VP, Clinical Science
• Organization: Takeda Global Research and Development Center, Inc.

clinicaltrialregistry@tpna.com

800-778-2860

Study Officials

• Principal, Clinical Pharmacology

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: July 12, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 18, 2013
• Results First Posted: October 18, 2013

Record last verified: 2013-08

Locations

DE (1)