drugset
drugset / Trial / NCT03776110

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GRT9906 Prolonged Release Tablets After Dose Escalation in Healthy Subjects

NCT03776110 ↗

Phase 1 Completed 48 enrolled Grünenthal GmbH
RandomizedSequentialQuadruple-blindTreatment

Summary

The safety and tolerability of multiple oral administrations of GRT9906 at different doses was investigated in this clinical study. The prolonged-release tablets slowly release the active compound in the intestine. In addition, absorption into the body, distribution, metabolization and excretion of GRT9906 was characterized. Pharmacological effects of GRT9906 in healthy participants was assessed using pupillometry (diameter and reactions of the pupil) and a Cold Pressor Test where pain is measured while hands are placed in icy water for two minutes.

Timeline

Start
2004-09-15
Primary completion
2005-03-23
Completion
2005-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject GRT9906 Unknown 80 mg Oral
Subject GRT9906 Unknown 120 mg Oral
Subject GRT9906 Unknown 160 mg Oral
Subject GRT9906 Unknown 200 mg Oral

Indications

No indication recorded.