Study to investigate the Safety, Tolerability and Pharmacokinetics of AZD1386 - MAD

Study identifier:D5090C00008

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 Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Caucasian young and elderly subjects after oral multiple doses.

Medical condition

Chronic Pain

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD1386, Placebo

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 80 Years

Date

Study Start Date: 01 Feb 2008

Primary Completion Date: 01 Oct 2008

Study Completion Date: 01 Oct 2008

Study design

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

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

MACCLESFIELD, Cheshire, United Kingdom

Arms	Assigned Interventions
Experimental: AZD1386 7 groups receiving a specified volume of the active component AZD1386 at different points of time.	Drug: AZD1386 Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol*h/L
Placebo Comparator: Placebo 7 groups receiving a specified volume of placebo at different points of time	Drug: Placebo Oral admin. of doses at 11 days through a 12 days period.

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=465&filename=CSR-D5090C00008.pdf
Download
CSR-D5090C00008.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Rolf Karlsten

Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden