Multiple ascending doses (MAD) of AZD3199 given once daily as inhaled formulation via Turbuhaler to healthy men - AZD3199MAD

Study identifier:D0570C00002

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A phase I, randomised, double-blind, placebo-controlled, parallel-group, single-centre study to investigate the safety, tolerability and pharmacokinetics of multiple ascending doses of AZD3199 (a B2-agonist) given once daily as inhaled formulation via Turbuhaler to healthy men

Medical condition

Healthy Volunteers

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD3199, Placebo

Sex

Male

Actual Enrollment

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Aug 2008

Primary Completion Date: 01 Nov 2008

Study Completion Date: 01 Nov 2008

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2014 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Lund, Sweden

Arms	Assigned Interventions
Experimental: 1 Low dose	Drug: AZD3199 Low dose Dry powder for inhalation, o.d., 1+12 days
Experimental: 2 intermediate dose	Drug: AZD3199 intermediate dose Dry powder for inhalation, o.d., 1+12 days
Experimental: 3 high dose	Drug: AZD3199 high dose Dry powder for inhalation, o.d., 1+12 days
Placebo Comparator: 4	-

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1662&filename=CSR-D0570C00002.pdf
Download
CSR-D0570C00002.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

Eva Pettersson

+46 46 336140

eva.s.pettersson@astrazeneca.com

Investigators

Principal Investigator

Gabriella Samuelsson Palmgren

AZ CPU Lund, Sweden