NCT03761407

A Clinical Study in Healthy Subjects Which Aims to Investigate the Safety, the Tolerability and the Effects of GRT0151Y and How the Compound is Taken up and Excreted From the Body

A Phase-I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Escalating Oral Doses of GRT0151Y in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this clinical study in healthy participants is to investigate the safety and tolerability of GRT0151Y after multiple oral intake of different increasing doses and to evaluate the pharmacological effects (action of the compound) by means of pupillometry (measuring the pupil size of the eye) and Cold Presser Test (measuring the pain when immersing the hand in 2 degree Celsius cold water). An additional aim of the study is to investigate the pharmacokinetics of GRT0151Y (how it is taken up into the body and how it is excreted from the body)."

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	100 mg GRT0151Y	100 mg capsule (1 x 100 mg capsule)
DRUG	125 mg GRT0151Y	125 mg (1 x 100 mg capsule and 1 x 25 mg capsule)
DRUG	150 mg GRT0151Y	150 mg (1 x 100 mg capsule and 1 x 50 mg capsule)
DRUG	225 mg GRT0151Y	Day 1: 150 mg (1 x 100 mg capsule and 1 x 50 mg capsule) Day 2 - 5: 225 mg (2 x 100 mg capsules and 1 x 25 mg capsule)
DRUG	Matching placebo	Matching placebo capsules using the same dosing regimen as defined in the treatment groups.

Timeline

• Start date: 2004-12-30
• Primary completion: 2005-07-26
• Completion: 2005-07-26
• First posted: 2018-12-03
• Last updated: 2018-12-03

Locations

1 site across 1 country: France