NCT03776110

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

Phase I, Single-center, Multiple Dose, Dose Escalation Study (Within Dose-group Randomised, Double-blind, Placebo-controlled, 2-way Cross-over) to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GRT9906 Prolonged Release Tablets in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Grünenthal GmbH · Industry
• Sex: All
• Age: 45 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

The primary objective of the study was to investigate the safety and tolerability of escalating doses of GRT9906 after multiple oral dose administration of prolonged-release (PR) tablets to healthy male and female participants Secondary objectives were: * To evaluate the pharmacokinetics (serum and urine) of escalating doses of GRT9906 after multiple oral dose administration of PR tablets and * To assess the pharmacodynamic effects of escalating doses of GRT9906 by means of pupillometry and Cold Pressor Test after multiple oral dose administration of PR tablets. The doses of GRT9906 in this study were 80, 120, 160, and 200 milligrams (mg) twice daily in dose groups 1-4. Participants were screened within 28 days prior to the first dosing. Treatment periods consisted of 5.6 (first dose group) or 6.6 (second and subsequent dose groups) days: * Day 0 was the day prior to first dosing * Day T was the titration day (day before Day M1; not applicable for the 80 mg dose group) * Days M1 to M4 were the days with repeated dosing * Days F1 and F2 were the follow-up days (24 hours and 48 hours after the last drug administration) * A final examination was performed within 4 to 14 days after last dosing.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	GRT9906 PR tablet	40 mg GRT9906 PR tablet oral (minimal release of 80 percent after 480 minutes)
DRUG	Placebo	Placebo tablet matching 40 mg GRT9906 PR tablet

Timeline

• Start date: 2004-09-15
• Primary completion: 2005-03-23
• Completion: 2005-03-23
• First posted: 2018-12-14
• Last updated: 2018-12-14

Locations

1 site across 1 country: Germany