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Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

Primary Purpose

Low Back Pain

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

AZD1940

Midazolam

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Pain, safety, chronic low back pain

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm Description

AZD1940 + Placebo

Outcomes

Primary Outcome Measures

Assessment of adverse events (AEs) occurring during the study, blood pressure (supine and standing), pulse rate, respiratory rate, body temperature, laboratory variables and ECG

Secondary Outcome Measures

Assessment of psychometric rating scales ( VAMS, CDR test battery, DEQ, ARCI and Bond-Lader)

To investigate the PK profile (including dose proportionality) of AZD1940 by assessment of plasma concentrations

Plasma levels of midazolam and 4ß hydroxycholesterol and 6β hydroxycortisol:cortisol urine excretion ratio as markers

Full Information

NCT ID

NCT00689780

First Posted

May 30, 2008

Last Updated

December 8, 2010

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00689780

Brief Title

Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Pain, safety, chronic low back pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

AZD1940 + Placebo

Arm Title

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

AZD1940

Intervention Description

Oral solution Multiple ascending dose given orally once daily at day 1-12

Intervention Type

Drug

Intervention Name(s)

Midazolam

Intervention Description

Oral solution given orally once daily on day -1 and day 14

Primary Outcome Measure Information:

Title

Assessment of adverse events (AEs) occurring during the study, blood pressure (supine and standing), pulse rate, respiratory rate, body temperature, laboratory variables and ECG

Time Frame

Vital signs, laboratory variables and adverse event each day throughout the study Paper printout ECG and/or digital ECG throughout the study

Secondary Outcome Measure Information:

Title

Assessment of psychometric rating scales ( VAMS, CDR test battery, DEQ, ARCI and Bond-Lader)

Time Frame

Psychometric tests and VAMS (Visual Analogue Mood Scale) throughout the study

Title

To investigate the PK profile (including dose proportionality) of AZD1940 by assessment of plasma concentrations

Time Frame

Bloodsampling Day 1,6, 10 and 15

Title

Plasma levels of midazolam and 4ß hydroxycholesterol and 6β hydroxycortisol:cortisol urine excretion ratio as markers

Time Frame

Bloodsampling at day -1, 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janet Post

Organizational Affiliation

AstraZeneca R&D SödertäljeSE

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Wolfgang Kühn

Organizational Affiliation

Quintiles AB Phase 1 Services Strandbodgatan Uppsala, Sweden+

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Linkoping

Country

Sweden

Facility Name

Research Site

City

Lulea

Country

Sweden

Facility Name

Research Site

City

Upssala

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

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