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In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2927 | Drug | Single dose of AZD2927 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of AZD2927, at screening | Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables at screening | |
| Safety and tolerability of AZD2927, day 1 | Monitoring of Adverse events, Electrocardiograms, vital signs, safety lab and ophtalmologic variables on day 1. | |
| Safety and tolerability of AZD2927, day 2 | Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab on day 2. | |
| Safety and tolerability of AZD2927, day 3 | Monitoring of Adverse events, Electrocardiograms, vital signs, and safety lab on day 3. | |
| Safety and tolerability of AZD2927, at follow up | Monitoring of Adverse events, Electrocardiograms, vital signs and safety lab at follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 1 | Pharmacokinetic sampling will be performed day 1 | |
| Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 2 | Pharmacokinetic sampling will be performed day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Kühn, MD | Quintiles AB | Principal Investigator |
| Helen Lunde, MD | AstraZeneca | Study Director |
| Mirjana Kujacic, MD | AstraZeneca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Sweden |
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| ID | Term |
|---|---|
| C000603099 | AZD2927 |
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| Drug |
Single dose of placebo |
|
| Pharmakokinetic for AZD2927 measured by Cmax, tmax, AUC, t1/2, CL and Vss, day 3 | Pharmacokinetic sampling will be performed day 3 |