NCT00925704CompletedPhase 1
A Phase I, Randomized, Open-Label, Three Period Cross-Over Study to Assess the Pharmacokinetics of Oral Calcitriol (ROCALTROL®) in Healthy Volunteers When Administered Alone or When Co-Administered With Lanthanum Carbonate (FOSRENOL®) or Sevelamer Carbonate (RENVELA®)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Shire
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol
Study Overview
Brief Summary
To assess the effects of lanthanum carbonate (FOSRENOL) or sevelamer carbonate (RENVELA) on the pharmacokinetics of oral calcitriol (ROCALTROL)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Calcitriol
Active Comparator
Intervention: Calcitriol (Drug)
Lanthanum carbonate + calcitriol
Experimental
Intervention: Lanthanum carbonate + Calcitriol (Drug)
Sevelamer carbonate + calcitriol
Experimental
Intervention: Sevelamer carbonate + Calcitriol (Drug)
Outcomes
Primary Outcomes
Area Under the Serum Concentration-time Curve (AUC 0-48) for Exogenous Calcitriol
Time Frame: 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 Outcomes
- 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)
- 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)
Investigators
Study Sites (1)
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