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

Pharmacokinetics Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Pharmacokinetics

Clinical Trial Details

NCT number	NCT03776110
Study type	Interventional
Source	Grünenthal GmbH
Contact
Status	Completed
Phase	Phase 1
Start date	September 15, 2004
Completion date	March 23, 2005

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04092725` - Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects	Phase 1
Completed	`NCT04181008` - Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers	Early Phase 1
Active, not recruiting	`NCT03258151` - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed	`NCT04406415` - Oral Nafamostat in Healthy Volunteers	Phase 1
Not yet recruiting	`NCT05421312` - Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip	Phase 4
Completed	`NCT02534753` - A Pharmacokinetics Study of Intravenous Ascorbic Acid	Phase 1
Completed	`NCT01976078` - Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents	N/A
Completed	`NCT01682408` - Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability	Phase 1
Completed	`NCT01636024` - To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594	Phase 1
Completed	`NCT01208155` - Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets	Phase 1
Completed	`NCT01214941` - Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol	Phase 4
Completed	`NCT01415102` - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.	Phase 1
Completed	`NCT01260025` - Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor	Phase 1
Completed	`NCT01276119` - The First Clinical Study to Test Safety, Blood Levels and Other Effects of CDP6038 in Healthy Males	Phase 1
Completed	`NCT00984009` - A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice	Phase 1
Completed	`NCT00746499` - Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.	Phase 1
Completed	`NCT01055964` - a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients	Phase 3
Completed	`NCT00983242` - Drug-Drug Interaction Between Colchicine and Verapamil ER	Phase 1
Completed	`NCT00856570` - A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects	Phase 1
Completed	`NCT00747721` - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.