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

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

NCT01578928•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Subjects eligible for inclusion in this study have to meet all of the following criteria:
•1. Written informed consent obtained prior to any screening procedures.
•2. Subjects must be able to communicate well with the investigator and comply with the requirements of the study procedures
•3. Male or female subjects between 18 and 75 years of age, inclusive.
•4. 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
•5. 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.
•6. Subjects must be willing to comply with dietary, fluid, and lifestyle restrictions (from day-1 to study completion).
•7. 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.
+10 more criteria

Exclusion Criteria

•Subjects eligible for this study must not meet any of the following criteria:
•1. 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
•2. 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)
•3. 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
+21 more criteria

Locations (2)

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Bloemfontein, Free State, South Africa

Key Dates

Start Date

May 1, 2012

Primary Completion Date

May 1, 2014

Completion Date

May 1, 2014

Last Updated

December 21, 2020

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

SOM230

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

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DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure