A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Volunteers
- Registration Number
- NCT01578928
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SOM230 SOM230 subjects with varying degrees of renal impairment along with subjects without renal impairment
- Primary Outcome Measures
Name Time Method Plasma and Urine 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 Description: Cmax, AUCinf, AUClast, CL/F, CLR, glucose, insulin, glucagon
- Secondary Outcome Measures
Name Time Method 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 Description: Vz/F, T1/2, Fu, Cmax,u, AUCinf,u, AUClast,u, CLu/F and Vu/F
Trial Locations
- Locations (1)
Novartis Investigative Site
🇿🇦Bloemfontein, Free State, South Africa