NCT01962935

Study to Investigate Safety, Tolerability and Effect of Multiple Dosing With AZD 4721 and/or With AZD 5069

A Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4721 After Once Daily Administration of Multiple Ascending Doses for 10 Days, and an Open-label Comparison With the Pharmacodynamics of AZD5069 Given Twice Daily for 3 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or with AZD 5069

Detailed description

The purpose of the study is to investigate the safety and tolerability, pharmacokinetics and pharmacodynamics of AZD 4721 in healthy volunteers after once daily administration of multiple ascending doses for 10 days, and an open-label comparison with the pharmacodynamics of AZD5069 given twice daily for 3 days

Conditions

• Chronic Obstructive Pulmonary Disease (COPD).

Interventions

Type	Name	Description
DRUG	AZD4721	Part A - multiple ascending dose, daily; Part B - one dose decided after part A, daily
DRUG	Placebo	Part A - multiple ascending dose daily
DRUG	AZD5069	Part B - one dose decided after part A, twice a day

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-10-16
• Last updated: 2015-06-25

Locations

1 site across 1 country: United Kingdom