Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase I, Multi-Centre, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940, Including an Interaction Study, After Administration of Oral Multiple Ascending Doses in Adult Subjects with Chronic Low Back Pain

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• A diagnosis of Chronic Low Back Pain according to Quebec Task force Class 1-3 and an average pain intensity score of 3-9 on NRS(0-10) during the past week.

• Clinical normal physical findings, including blood pressure, pulse rate > 45bpm, ECG (with normal QTcF interval <450msec and without any additional risk factors for Torsades de Pointes) and laboratory assessments, as judged by investigator

• Body Mass Index (BMI) ≥18 to ≤32 kg/m2 inclusive and body weight ≥50 to ≤100 kg

Exclusion Criteria:

• History of somatic disease/condition which may interfere with the objectives of the study, with the exception of Chronic Low Back Pain

• History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder

• Clinically significant illness with the exception of Chronic Low Back Pain