Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940 - Full Text View

Purpose

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

Condition	Intervention	Phase
Low Back Pain	Drug: AZD1940 Drug: Midazolam	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Drug Reactions

Drug Information available for: Midazolam hydrochloride

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 [ Time Frame: Vital signs, laboratory variables and adverse event each day throughout the study Paper printout ECG and/or digital ECG throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
To investigate the PK profile (including dose proportionality) of AZD1940 by assessment of plasma concentrations [ Time Frame: Bloodsampling Day 1,6, 10 and 15 ] [ Designated as safety issue: No ]
Plasma levels of midazolam and 4ß hydroxycholesterol and 6β hydroxycortisol:cortisol urine excretion ratio as markers [ Time Frame: Bloodsampling at day -1, 14 ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	March 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 AZD1940 + Placebo	Drug: AZD1940 Oral solution Multiple ascending dose given orally once daily at day 1-12
2	Drug: Midazolam Oral solution given orally once daily on day -1 and day 14

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689780

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

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

More Information

No publications provided

Responsible Party:	Rolf Karlsten, AstraZeneca R&D Södertälje
ClinicalTrials.gov Identifier:	NCT00689780 History of Changes
Other Study ID Numbers:	D3120C00003
Study First Received:	May 30, 2008
Last Updated:	December 8, 2010
Health Authority:	Sweden: Medical Products Agency Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

Pain
safety
chronic low back pain

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents

Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013