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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD1940 + Placebo |
|
| 2 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1940 | Drug | Oral solution Multiple ascending dose given orally once daily at day 1-12 |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Post | AstraZeneca R&D SödertäljeSE | Study Chair |
| Wolfgang Kühn | Quintiles AB Phase 1 Services Strandbodgatan Uppsala, Sweden+ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Linköping | Sweden | ||||
| Research Site |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C582877 | N-(2-tert-butyl-1-((4,4-difluorocyclohexyl)methyl)-1H-benzo(d)imidazol-5-yl)ethanesulfonamide |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam |
| Drug |
Oral solution given orally once daily on day -1 and day 14 |
|
| 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 |
| Luleå |
| Sweden |
| Research Site | Upssala | Sweden |
| D006571 | Heterocyclic Compounds |