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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Research Site
Linköping, Sweden
Research Site
Luleå, Sweden
Research Site
Upssala, Sweden
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
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
To investigate the PK profile (including dose proportionality) of AZD1940 by assessment of plasma concentrations
Time frame: Bloodsampling Day 1,6, 10 and 15
Plasma levels of midazolam and 4ß hydroxycholesterol and 6β hydroxycortisol:cortisol urine excretion ratio as markers
Time frame: Bloodsampling at day -1, 14
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