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
69
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
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| 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. |
Contacts
Investigators
Principal Investigator
Rolf Karlsten
Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden
