Human Pharmacology Trial of Calcium-vitamin D3 Tablet in Healthy Participants
Information source: Takeda
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Calcium Deficiency; Vitamin D Deficiency
Intervention: Calcium 500 mg and Vitamin D3 800 IU (Drug); Low calcium meals (Other)
Phase: Phase 1
Status: Completed
Sponsored by: Takeda Official(s) and/or principal investigator(s): Principal, Clinical Pharmacology, Study Director, Affiliation: Takeda
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.
Clinical Details
Official title: A Two Period, One-sequence Open-label Study of a Newly Developed Calcium Carbonate-vitamin D3 Chewable Tablet Formulation (Calcium 500 mg and Vitamin D3 800) Dosed for Three Days to Investigate the Effect on Urine Calcium and Serum Parathyroid Hormone (PTH) as Measurements of Intestinal Calcium Absorption in Healthy Postmenopausal Women and Healthy Men Compared to Baseline.
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Amount of Calcium Excreted in Urine From 0 Hours up to 6 Hours Post Dose (Ca2+ Ae0-6h)Area Under the Curve From 0 to 6 Hours Post Dose of Parathyroid Hormone (PTH AUC0-6h) in Serum
Secondary outcome: Amount of Calcium Excreted in Urine From 0 to 6 Hours Post Dose Corected for Creatinine (Ae0-6h/Creatinine)
Detailed description:
The drug being tested in this study is called Calcichew. This study will look at calcium
absorption in healthy postmenopausal women and healthy men.
The study will enroll approximately 55 healthy adults. All participants will receive
Calcichew.
All participants will be asked to take one chewable tablet at the same time each day for
three days in period 2 of the trial.
This trial will be conducted at one clinical site in Germany. The overall time to
participate in this study is 4 weeks. Participants will make 9 visits to the clinic, and
will be contacted by telephone 7days after last dose of study drug for a follow-up
assessment.
Eligibility
Minimum age: 45 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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
2. 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
3. Is Caucasian
4. Is assessed as healthy based on physical examination, medical history, clinical
laboratory, electrocardiogram (ECG), vital signs
5. Is a non-smoker (having abstained from smoking for at least 6 months)
6. Has a body mass index of 19 to 29. 4 kg/m^2 (inclusively)
Exclusion Criteria:
1. Has a history of clinically significant allergies or idiosyncrasies to calcium or
vitamin D3, or any inactive ingredient(s) of these products
2. Is a lactating or pregnant female participant
3. Female participants: Has a positive pregnancy test in serum at screening and in urine
on Day - 1 Period 1
4. Participant was previously enrolled into the current clinical trial
5. 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
6. 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
7. 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)
8. Has a hypersensitivity to soya or peanut
9. Abuse of alcohol or drugs
10. Has consumed ethanol within 48 hours prior to hospitalization verified by alcohol
breath test (Alcotest®)
11. 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
12. Has creatinine clearance according to Modification of Diet in Renal Disease (MDRD)
equation of < 60 mL/min
13. 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
14. 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
15. 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
16. Has unusual diet habits and practicing vegetarians
17. Has beverages and food containing poppy seed (i. e. poppy seed rolls, poppy seed cake,
milk shakes containing poppy seed) from 72 hours before drug screen to avoid
interference
18. Has chinine, grapefruit- and star fruit-containing beverages and food, St. John's
wort (known Cytochrome P450 (CYP450) inhibitors and inducers) within 7 days prior to
hospitalization
19. Has excessive consumption of caffeinated beverages (more than five cups of coffee or
equivalent per day)
20. Has consumption of xanthine-containing beverages and food (e. g. coffee, black and
green tea, cola, chocolate) 48 hours prior to hospitalization
21. Has evidence of acute or chronic hepatitis B or C. Positive test for hepatitis B
surface antigen (HBsAg), antibody to the hepatitis B core antigen (anti-HBc) or
antibody to the hepatitis C virus (anti-HCV antibody), or human immunodeficiency
virus (HIV) infection at screening
22. Has history of gastrointestinal surgery (except appendectomy) or any other
gastrointestinal condition or disease that might influence (calcium) absorption
23. Has any condition, including laboratory findings or findings in the medical history
or screening assessments that, in the opinion of the Investigator, constitutes a
specific risk or a contraindication for the participant's participation in the trial
or that could interfere with the trial objectives, conduct or evaluation
24. Has any comedication required during the trial.
Locations and Contacts
Mannheim, Baden-Württemberg, Germany
Additional Information
Starting date: July 2012
Last updated: August 13, 2013
|