NCT02647697

Study to Evaluate Properties of Radiprodil Given in Oral Solution to Healthy Volunteers

A Single Oral Dose Study of the Safety, Tolerability, and Pharmacokinetic Profile of Radiprodil in Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: UCB Biopharma S.P.R.L. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the pharmacokinetics (PK) profile of Radiprodil in suspension form in healthy adult subjects.

Detailed description

UP0027 is a Phase 1, single-center, open-label study to investigate the safety, tolerability, and PK profile of radiprodil in healthy adult male and female subjects after a single fasting oral dose of radiprodil 30 mg suspension formulation. A total of 10 subjects will be enrolled in the study. The primary objective of the study is to evaluate the PK profile of oral radiprodil in suspension form in healthy adult subjects. The secondary objective of the study is to evaluate the safety and tolerability of oral radiprodil in suspension form in healthy adult subjects. The exploratory objectives of the study are to evaluate the comparative PK profile of radiprodil from samples collected using 2 alternative microsampling techniques (MITRA™ and Drummond capillary tubes) with that of conventional venous blood samples, and to test the perception of the taste and texture of the oral radiprodil suspension.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Radiprodil oral	* Active Substance: Radiprodil * Pharmaceutical Form: dry granules for oral suspension * Concentration: 30 mg * Route of Administration: oral use

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2016-01-06
• Last updated: 2016-02-10

Locations

1 site across 1 country: Netherlands