A Phase I, Open-label, Multicenter, Single Dose Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous (s.c.) Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to a Matched Control Group of Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- SOM230
- Conditions
- Renal Impairment
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Plasma and Urine PK parameters
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of pasireotide,the PK of pasireotide in subjects with different degrees of renal impairment.
Detailed Description
This is a phase I, open-label, multicenter, single dose study to evaluate the PK and safety of pasireotide s.c. injection in subjects with varying degrees of renal impairment compared to healthy subjects with normal renal function. Subjects will be classified by their respective degree of renal functions (normal, mild, moderate, severe, and ESRD (End Stage Renal Disease) according to eGFR as determined at the screening visit.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
SOM230
subjects with varying degrees of renal impairment along with subjects without renal impairment
Intervention: SOM230
Outcomes
Primary Outcomes
Plasma and Urine PK parameters
Time Frame: pre-dose (-1 min) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12, 24, 36, 48, 72, 96, 120 and 122 hours post-dose
Description: Cmax, AUCinf, AUClast, CL/F, CLR, glucose, insulin, glucagon
Secondary Outcomes
- Additional PK parameters(pre-dose (-1 min) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 24, 36, 48, 72, 96, 120 and 122 hours post-dose)