Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

Phase 1

Completed

• Conditions: Low Back Pain
• Interventions: Drug: AZD1940; Drug: Midazolam

• Registration Number: NCT00689780
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-04
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-08
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD1940	AZD1940 + Placebo
2	Midazolam	-

Primary Outcome Measures

Name	Time	Method
Assessment of adverse events (AEs) occurring during the study, blood pressure (supine and standing), pulse rate, respiratory rate, body temperature, laboratory variables and ECG	Vital signs, laboratory variables and adverse event each day throughout the study Paper printout ECG and/or digital ECG throughout the study

Secondary Outcome Measures

Name	Time	Method
Assessment of psychometric rating scales ( VAMS, CDR test battery, DEQ, ARCI and Bond-Lader)	Psychometric tests and VAMS (Visual Analogue Mood Scale) throughout the study
To investigate the PK profile (including dose proportionality) of AZD1940 by assessment of plasma concentrations	Bloodsampling Day 1,6, 10 and 15
Plasma levels of midazolam and 4ß hydroxycholesterol and 6β hydroxycortisol:cortisol urine excretion ratio as markers	Bloodsampling at day -1, 14

Trial Locations

Locations (1)

Research Site; 🇸🇪 Upssala, Sweden