The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Calcitriol; Drug: Lanthanum carbonate + Calcitriol; Drug: Sevelamer carbonate + Calcitriol

• Registration Number: NCT00925704
• Lead Sponsor: Shire

Brief Summary

To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-01
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Primary Completion: 2009-07-31
• Study Completion: 2009-07-31
• Results First Submitted: 2010-03-19
• Results First Submitted QC: 2010-04-21
• Results First Posted: 2010-05-14
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Calcitriol	Calcitriol	-
Lanthanum carbonate + calcitriol	Lanthanum carbonate + Calcitriol	-
Sevelamer carbonate + calcitriol	Sevelamer carbonate + Calcitriol	-

Primary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol	pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose	This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.

Secondary Outcome Measures

Name	Time	Method
Time of Maximum Plasma Concentration (Tmax) for Exogenous Calcitriol	pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose	This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.
Maximum Plasma Concentration (Cmax) for Exogenous Calcitriol	pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, and 48 hours post calcitriol dose	This shows the effect that lanthanum carbonate or sevelamer carbonate has on the pharmacokinetics of oral calcitriol. Exogenous calcitriol was the difference between total calcitriol value and the baseline exogenous calcitriol value at each sampling timepoint.

Trial Locations

Locations (1)

West Coast Clinical Trials; 🇺🇸 Cypress, California, United States