A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Volunteers

NCT01578928 | Completed Phase 1

• 2 other identifiers: CSOM230B21262011-005922-23
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 2

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.

Conditions

Renal Impairment

Keywords

renal, impairment, endstage renal disease; renal; impairment; endstage renal disease

Outcome Measures

Primary Outcomes (1)

• Plasma and Urine PK parameters

  Description: Cmax, AUCinf, AUClast, CL/F, CLR, glucose, insulin, glucagon

  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

Secondary Outcomes (1)

• 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

Study Arms (1)

SOM230

EXPERIMENTAL

subjects with varying degrees of renal impairment along with subjects without renal impairment

Drug: SOM230

Interventions

SOM230 DRUG

SOM230

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained prior to any screening procedures.
• Subjects must be able to communicate well with the investigator and comply with the requirements of the study procedures
• Male or female subjects between 18 and 75 years of age, inclusive.
• Vital Signs at screening and baseline which are within the following ranges:
• Oral body temperature: ≥ 35.0 and ≤ 37.5 ˚C
• Pulse rate: 40-90 bpm
• Subjects must have a BMI between 20 kg/m2 and 30 kg/m2 and weigh at least 50 kg and no more than 120 kg.
• Subjects must be willing to comply with dietary, fluid, and lifestyle restrictions (from day-1 to study completion).
• Other than renal impairment, subjects must be stable and appropriately managed relative to chronic diseases (such as diabetes and hypertension) as determined by past medical history, physical examination, electrocardiogram, and laboratory tests for chemistry and hematology.
• For renal impairment subjects only
• Subjects must have stable renal disease without evidence of renal progressive disease (stable renal disease is defined as no significant change, such as, stable eGFR, for 12 weeks prior to study entry).
• Blood pressure (3 minutes resting before measurement) in the supine position:
• Systolic: 90-165 mmHg
• Diastolic: 60-110 mmHg
• For control subjects only

You may not qualify if:

• Subjects eligible for this study must not meet any of the following criteria:
• Clinically significant abnormal laboratory values at the screening evaluation or at the baseline re-evaluation, excluding those normally associated with mild to severe degree of renal impairment or the primary cause of renal insufficiency
• Use of any over-the-counter medications or vitamins or herbal/natural supplements during 2 weeks prior to dosing (acetaminophen is acceptable, and must be documented in the Concomitant Medications/Non-Drug Therapies page of the CRF)
• Current medical history of the following:
• Sustained or clinically significant cardiac arrhythmias
• History of syncope or family history of idiopathic sudden death
• Risk factors for torsades de pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant/symptomatic bradycardia, or high grade AV block
• Screening QTcF \> 450ms
• Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
• Concomitant medications known to increase the QT interval
• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation
• Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or other amount considered to compromise the health of the subject if previous history of anemia exists
• Significant acute illness within the two weeks prior to dosing
• History of immunocompromise, including a positive HIV (ELISA and Western blot) test result
• History of allergies to the investigational compound/compound class being used in the study

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Novartis Investigative Site

Berlin, 14050, Germany

Location

Novartis Investigative Site

Bloemfontein, Free State, 9300, South Africa

Location

Related Links

• Results for CSOM230B2126 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Renal Insufficiency

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 17, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 21, 2020

Record last verified: 2020-09

Locations

DE (1); ZA (1)