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The purpose of this study is to assess safety, tolerability and pharmacokinetics of TC-5214 in elderly healthy Japanese volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TC-5214 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TC-5214 | Drug | Tablet, Oral, twice daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| assess the safety and tolerability during single and multiple ascending oral doses by assessment of AEs, brief neurological examinations, vital signs, eye symptoms question, physical examinations, laboratory parameters, and ECGs, and C-SSRS. | During the whole study period, ca. 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| characterise the PK of TC-5214 in plasma and urine during single and multiple ascending oral doses to Japanese healthy elderly volunteers. | PK samplings are taken at defined timepoints during residential periods, 4 days for SAD part and/or 9 days for MAD part. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans Eriksson, MD | AstraZeneca | Study Director |
| Shunji Matsuki, MD | Kyushu Clinical Pharmacology Research Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Fukuoka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24408516 | Derived | Xu H, Henningsson A, Alverlind S, Tummala R, Toler S, Beaver JS, Al-Huniti N. Population pharmacokinetics of TC-5214, a nicotinic channel modulator, in phase I and II clinical studies. J Clin Pharmacol. 2014 Jun;54(6):707-18. doi: 10.1002/jcph.264. Epub 2014 Jan 16. |
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| Drug |
Tablet, Oral, twice daily |
|