Vitamin D3, Folic Acid and Fexofenadine in Healthy Volunteers

NCT01856348 | Completed Phase 1

• 1 other identifier: PHA-11-VID/FOL-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The study is conducted to assess the effect of a vitamin D3 supplementation on the activities of two intestinal transporters and on the pharmacokinetics of the transporter substrates folic acid and fexofenadine.

• Trial with medicinal product

Conditions

Physiological Effects of Vitamin D

Outcome Measures

Primary Outcomes (2)

• Ratio of the area under the concentration vs. time curve (AUC) of fexofenadine after vitamin D over AUC of fexofenadine before vitamin D

  Changes in single-dose pharmacokinetics of racemic fexofenadine at the end of a substitution with 1,25 dihydroxyvitamin D3 in comparison to pharmacokinetics before the substitution.

  10 days

• Ratio of Area under the concentration vs. time curve (AUC) of folic acid after vitamin D over AUC of folic acid before vitamin D

  Changes in single-dose pharmacokinetics of folic acid at the end of a substitution with 1,25 dihydroxyvitamin D3 in comparison to pharmacokinetics before the substitution.

  10 days

Secondary Outcomes (2)

• Number and characteristics of participants with adverse events

  10 days

• transporter mRNA quantity

  10 days

Study Arms (1)

1, 25 dihydroxyvitamin D3 intake

EXPERIMENTAL

This is a single arm study.

Drug: Vitamin D

Interventions

Vitamin D DRUG

1, 25 dihydroxyvitamin D3 intake

Eligibility Criteria

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

You may qualify if:

• male or female
• age 18 to 65 years at study entry
• signed informed consent form
• Body Mass Index \> 18 - \< 30 kg/m2
• Participants must not have any other diseases (as assessed by the screening examination)
• Participants must not take any concomitant medications except oral contraceptives in females
• Normal blood count

You may not qualify if:

• Subjects with confirmed or suspected hypersensitivity towards the study medications
• Contemporaneous participation in any other study
• Females only: pregnancy
• Females only: breast-feeding
• Clinically significant abnormal laboratory findings
• Known or suspected present or past malignancies of any kind
• Known or suspected active infections, serious infections in the preceding 3 months
• Positive hepatitis B, hepatitis C and / or HIV 1/2 serology
• Subjects known or suspected not to comply with the study regulations
• Subjects employed at the participating departments of the University Hospital Zürich.
• Known or suspected present or past diseases which may interfere with the study
• smokers
• alcohol or drug abuse

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Dept. of Clinical Pharmacology and Toxicology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Gerd A Kullak-Ublick, Prof MD

  University Hospital Zurich, Pharmacology and Toxicology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: May 17, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

CH (1)