drugset / Trial / NCT02393950

Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of ODM-106 in Healthy Volunteers

NCT02393950 ↗

Phase 1 Completed 16 enrolled Orion Corporation, Orion Pharma
RandomizedCrossoverQuadruple-blindBasic science

Summary

The study is a dose escalation study with 8 planned dose levels. The study is a 4-period crossover design where each healthy volunteer will be randomised to receive three dose levels of ODM-106 (single doses) and one dose of placebo. The study will look at the pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-106.

Timeline

Start
2015-03
Primary completion
2015-10
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject ODM-106 Unknown — Oral

Indications

No indication recorded.