Absorption, Metabolism and Excretion Study of [14C]PBT2 and Absolute Bioavailability of PBT2
This study has been completed.
Sponsor:
Prana Biotechnology Limited
Information provided by (Responsible Party):
Prana Biotechnology Limited
ClinicalTrials.gov Identifier:
NCT02249728
First received: July 30, 2014
Last updated: September 25, 2014
Last verified: September 2014
The purpose of the study is to investigate how the test drug, PBT2, is taken up, broken down and removed from the body when given as an oral capsule, a radiolabelled oral suspension and a radiolabelled intravenous injection.
Condition Intervention Phase 1 Healthy Volunteers Drug: IV PBT2 microtracer and oral PBT2 single doseDrug: oral 14C-PBT2 Phase 1
Study Type: Interventional 1 Study Design: Allocation: Non-RandomizedEndpoint Classification: Pharmacokinetics StudyIntervention Model: Single Group AssignmentMasking: Open LabelPrimary Purpose: Basic Science 2 Official Title: A Phase I , Open-Label Study to Evaluate the Absorption, Metabolism and Excretion of [14C]-PBT2 and to Estimate the Absolute Bioavailability of PBT2 in Healthy Male Subjects
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