Clinical trial NCT00689780: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Low Back Pain
Keywords: Pain
safety
chronic low back pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Assessment of adverse events (AEs) occurring during the study, blood pressure (supine and standing), pulse rate, respiratory rate, body temperature, laboratory variables and ECG
timeFrame: Vital signs, laboratory variables and adverse event each day throughout the study Paper printout ECG and/or digital ECG throughout the study
Secondary outcomes:
measure: Assessment of psychometric rating scales ( VAMS, CDR test battery, DEQ, ARCI and Bond-Lader)
timeFrame: Psychometric tests and VAMS (Visual Analogue Mood Scale) throughout the study
measure: To investigate the PK profile (including dose proportionality) of AZD1940 by assessment of plasma concentrations
timeFrame: Bloodsampling Day 1,6, 10 and 15
measure: Plasma levels of midazolam and 4ß hydroxycholesterol and 6β hydroxycortisol:cortisol urine excretion ratio as markers
timeFrame: Bloodsampling at day -1, 14
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Upssala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D SödertäljeSE
name: Janet Post
role: STUDY_CHAIR
affiliation: Quintiles AB Phase 1 Services Strandbodgatan Uppsala, Sweden+
name: Wolfgang Kühn
role: PRINCIPAL_INVESTIGATOR
References: