Effect of Calcium 500 mg and Vitamin D3 1000 IU Chewable Tablet on Intestinal Calcium Absorption

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02338713
• Other study ID #: Calcichew-1001
• Secondary ID: U1111-1163-17512
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2014
• Last updated: March 18, 2015
• Start date: January 2015
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Agency for Medicines and Health Products Safety
• Study type: Interventional

Clinical 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 mg and vitamin D3 1000 IU) increases the amount of calcium excreted in urine and decreases parathyroid hormone (PTH) in serum as compared with Baseline.

Description:

The drug being tested in this study is called Calcichew D3. Calcichew D3 is being tested to assess how it is processed by the body in healthy men and postmenopausal women. This study will look at lab results in people who take Calcichew D3.

The study will enroll approximately 27 patients. All participants will receive the same treatment:

• Calcichew D3 (calcium 500 mg and vitamin D3 1000 IU) chewable tablets All participants will be asked to take one tablet each morning of the treatment period.

This single-centre trial will be conducted in France. The overall time to participate in this study is up to 44 days. Participants will make 2 visits to the clinic, including one 7-day period of confinement to the clinic, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

Inclusion Criteria:

1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.

2. 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.

3. Is a healthy adult male or female participant.

4. Female participants should be postmenopausal (last menses at least 2 years before signing informed consent and follicle-stimulating hormone (FSH) confirming postmenopausal status).

5. The participant is White.

6. Is aged 45 to 70 years, inclusive, at the time of informed consent and study enrollment.

7. Weighs at least 50 kg and has a body mass index (BMI) from 18 to 30 kg/m^2, inclusive at Screening and Day -1.

8. Is a nonsmoker (having abstained from smoking for at least 6 months).

Exclusion Criteria:

1. Has received any investigational compound within 30 days prior to Screening.

2. 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 (eg, spouse, parent, child, sibling) or may consent under duress.

3. 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.

4. Has a known hypersensitivity to calcium or vitamin D3 or to any of the excipients of the formulation of the Calcichew D3 chewable tablet.

5. Has a positive urine drug result for drugs of abuse (defined as any illicit drug use) at Screening or Check-in (Day -1).

6. 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).

7. Has taken any excluded medication, supplements, or food products during the time periods listed in the Excluded Medications and Dietary Products table.

8. 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]).

9. Has a history of cancer, except basal cell carcinoma that has been in remission for at least 5 years prior to Day 1.

10. 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.

11. 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).

12. Has poor peripheral venous access.

13. Has donated or lost 450 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.

14. 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.

15. 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) >2.0 times the upper limit of normal (ULN).

16. Is a practicing vegetarian or vegan.

17. Has a creatinine clearance according to Modification of Diet in Renal Disease equation of <60 mL/min at Screening or Check-in (Day -1).

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Calcichew D3
Calcium 500 mg and vitamin D3 1000 IU chewable tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Serum Concentration-Time Curve from Time 0 to 6 Hours Post-dose of Parathyroid Hormone (PTH AUC6)		0 to 6 Hours on Day 3 and Day 6	No
Primary	Amount of Calcium Excreted in Urine from Time 0 to 6 Hours Post-dose (Ca^2+ Ae6)		0 to 6 Hours on Day 3 and Day 6	No
Secondary	Area Under the Serum Concentration-Time Curve from Time 0 to 24 Hours Post-dose of Parathyroid Hormone (PTH AUC24)		0 to 24 Hours on Days 3 and 6	No
Secondary	Amount of Calcium Excreted in Urine from Time 0 to 24 Hours Post-dose (Ca^2+ Ae24)	Total amount of drug excreted in urine from time 0 to 24 hours.	0 to 24 Hours on Days 3 and 6	No
Secondary	Cmax: Maximum Observed Serum Concentration of Calcium	Maximum observed serum concentration (Cmax) is the peak serum concentration of a drug after administration, obtained directly from the serum concentration-time curve.	Days 3 and 6	No
Secondary	Area Under the Serum Concentration-Time Curve from Time 0 to 6 Hours Post-dose (AUC6) of Calcium		0 to 6 Hours on Days 3 and 6	No
Secondary	Area Under the Serum Concentration-Time Curve from Time 0 to 24 Hours Post-dose (AUC24) of Calcium		0 to 24 Hours on Days 3 and 6	No
Secondary	Tmax: Time to Reach the Maximum Serum Concentration (Cmax) of Calcium	Tmax: Time to reach the maximum serum concentrations (Cmax), equal to time (hours) to Cmax.	Days 3 and 6	No
Secondary	Number of Participants Who Experience at Least 1 Treatment-Emergent Adverse Event	An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event is defined as an adverse event with an onset that occurs after receiving study drug.	Day 1 to 14 days after the last dose of study medication (up to Day 21)	Yes