Trials / Completed
CompletedNCT02396953
Study to Determine the Maximum Tolerated Dose, Safety and Tolerability of a Single Dose of Lanreotide Prolonged Release Formulation (PRF) in Subjects With Acromegaly
Phase IIa, Open Label, Dose Ascending Study to Determine the Maximum Tolerated Dose, Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Lanreotide PRF in Subjects With Acromegaly Previously Treated and Controlled With Either Octreotide LAR or Lanreotide Autogel
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | Lanreotide PRF |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2017-11-28
- Completion
- 2017-11-28
- First posted
- 2015-03-24
- Last updated
- 2019-04-25
- Results posted
- 2019-04-25
Locations
36 sites across 12 countries: Belgium, Czechia, France, Germany, Italy, Lithuania, Netherlands, Poland, Romania, Russia, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02396953. Inclusion in this directory is not an endorsement.