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Study to Determine the Maximum Tolerated Dose, Safety and Tolerability of a Single Dose of Lanreotide Prolonged Release Formulation (PRF) in Subjects With Acromegaly

NCT02396953 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-04-25

Study results available
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Summary

The objectives of the protocol is to determine the maximum tolerated dose and to investigate the pharmacokinetics of a single dose of lanreotide PRF in subjects with acromegaly.

Conditions

Interventions

DRUG

Lanreotide PRF

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-11-28
Completion
2017-11-28

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • Russia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02396953 on ClinicalTrials.gov