NCT01215084

A Pharmacokinetics (PK) and Safety Study of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers

A Single-Dose, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Fampridine-PR 10 mg in Chinese, Japanese, and Caucasian Adult Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to determine the Pharmacokinetic (PK) and safety profiles of fampridine-PR 10 mg in Chinese and Japanese adult healthy volunteers. The secondary objective of this study is to compare the PK and safety profiles of fampridine-PR 10 mg among the Chinese, Japanese, and Caucasian adult healthy volunteers.

Detailed description

The Caucasian group is included to allow comparison of pharmacokinetic and safety data from different race groups to be performed with data obtained from the same study under the same controlled conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BIIB041 (Fampridine-PR)	A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-10-06
• Last updated: 2014-07-09

Locations

2 sites across 2 countries: Australia, Hong Kong