Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: AZD1940; Drug: Midazolam

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Linkoping, Sweden
    • Research Site
  • Lulea, Sweden
    • Research Site
  • Upssala, Sweden
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 2	Drug: Midazolam; Oral solution given orally once daily on day -1 and day 14
Experimental: 1; AZD1940 + Placebo	Drug: AZD1940; Oral solution Multiple ascending dose given orally once daily at day 1-12

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Chair: Janet Post, AstraZeneca R&D SödertäljeSE; Principal Investigator: Wolfgang Kühn, Quintiles AB Phase 1 Services Strandbodgatan Uppsala, Sweden+

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): November 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: May 30, 2008
• First Submitted That Met QC Criteria: June 3, 2008
• First Posted (Estimate): June 4, 2008

Study Record Updates

• Last Update Posted (Estimate): December 10, 2010
• Last Update Submitted That Met QC Criteria: December 8, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: safety; Pain; chronic low back pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: D3120C00003