Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00446082
NCT00446082
Completed
Phase 1

A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease

Novartis Pharmaceuticals5 sites in 2 countries85 target enrollmentJune 2006
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsCarcinoid TumorAcromegaly
InterventionsPasireotide
DrugsPasireotide

Overview

Phase
Phase 1
Intervention
Pasireotide
Conditions
Carcinoid Tumor
Sponsor
Novartis Pharmaceuticals
Enrollment
85
Locations
5
Primary Endpoint
Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This study will assess the pharmacokinetic profile and the safety/tolerability profile of single and monthly doses of pasireotide LAR intramuscular (i.m.) injection in patients with acromegaly and patients with carcinoid disease

Registry
clinicaltrials.gov
Start Date
June 2006
End Date
November 2013
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

SOM230 LAR

Intervention: Pasireotide

Outcomes

Primary Outcomes

Determination of the pharmacokinetic profile of single and monthly doses of pasireotide LAR i.m. injection

Time Frame: Baseline, D7, D35, D63

in patients with acromegaly and in patients with carcinoid disease

Secondary Outcomes

  • To explore the pharmacodynamic profile of single and monthly doses of pasireotide LAR i.m. injection(Baseline, D7, D35, D63)

Study Sites (5)

Loading locations...

Similar Trials

Completed
Phase 1
TMC435 HPC1004 - Phase I Study Investigating the Pharmacokinetics of TMC435 in Healthy Chinese VolunteersHepatitis C
NCT01224197Tibotec Pharmaceuticals, Ireland32
Completed
Phase 1
To Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of TG-1000 in Healthy Volunteers, and the Food Effect on Pharmacokinetics of Single Oral Dose of TG-1000 in Healthy Volunteers.Healthy Chinese Volunteers
NCT04495322TaiGen Biotechnology Co., Ltd.66
Completed
Phase 1
A Study to Assess Safety, Tolerability and Pharmacokinetics of Ceftaroline in Healthy SubjectsHealthy Volunteers
NCT01612507Pfizer41
Completed
Phase 1
Phase1a, Dose-escalation Study of NNI-362 in Healthy Aged VolunteersAlzheimer Disease
NCT04074837Neuronascent, Inc.56
Completed
Phase 1
To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses AZD8848 in Healthy SubjectsSafety,Tolerability,Healthy Subjects
NCT01818869AstraZeneca8