NCT01216384

Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers

A Randomised, Double-blind (Within Dose Groups), Parallel Group, Placebocontrolled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Rising Doses (50 mg, 200 mg, 400 mg) of BI 671800 HEA in Chinese Healthy Male Volunteers and Multiple Rising Doses (50 mg b.i.d., 200 mg b.i.d., 400 mg b.i.d.) of BI 671800 HEA in Japanese Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the current study is to investigate the safety and tolerability of BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and healthy Japanese male volunteers following single oral administration and multiple administrations.

Conditions

• Asthma
• Rhinitis, Allergic, Perennial

Interventions

Type	Name	Description
DRUG	BI 671800	In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses.
DRUG	placebo	Subjects will receive according to the dose group matching number of placebo tablets

Timeline

• Start date: 2010-10-01
• Primary completion: 2010-12-01
• First posted: 2010-10-07
• Last updated: 2013-11-19

Locations

1 site across 1 country: South Korea