Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1940

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: AZD1940
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, safety, chronic low back pain