Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Low Back Pain

Treatments: Drug: Midazolam; Drug: AZD1940

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689780

D3120C00003

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

1

Experimental group

Description:

AZD1940 + Placebo

Treatment:

Drug: AZD1940

2

Other group

Treatment:

Drug: Midazolam