Status:
COMPLETED
The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers
Lead Sponsor:
Shire
Conditions:
Healthy
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)
Eligibility Criteria
Inclusion
- Inclusion criteria
- Healthy volunteers age 19-45 years inclusive at the time of consent.
- Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, electrocardiogram (ECG) and laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the Investigator.
- No current or recurrent disease (e.g. cardiovascular, renal, liver, gastrointestinal (GI), malignancy or other conditions) that could affect the action, absorption or disposition of the investigational products utilized in this study, or could affect clinical or laboratory assessments.
- Exclusion criteria
- Current or recurrent disease (eg, cardiovascular, renal, liver, GI, malignancy or other conditions) that could affect the action, absorption or disposition of the investigational products utilized in this study, or could affect clinical or laboratory assessments.
- Current or relevant previous of physical or psychiatric illness, any medical disorder that could have required treatment or made the subject unlikely to fully complete the study, or any condition that presented undue risk from the investigational product or study procedures.
- Current use of any medication with the exception of hormonal replacement therapy or hormonal contraceptives within 14 days of first dose of investigational product.
- History of alcohol or other substance abuse within the last year.
- A positive human immunodeficiency virus antibody screen, Hepatitis B surface antigen or Hepatitis C virus antibody screen.
- Use of tobacco in any form
- Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to receiving the first dose of investigational product.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2009
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00925704
Start Date
June 1 2009
End Date
July 31 2009
Last Update
June 15 2021
Active Locations (1)
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1
West Coast Clinical Trials
Cypress, California, United States, 90630