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The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy subjects.
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of NKTR-118 following single and multiple ascending oral dose administration in healthy young and elderly Japanese subjects, and an Open Randomized, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics after single oral doses of NKTR-118 in healthy male Japanese subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NKTR-118 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKTR-118 | Drug | Tablet, Oral, Once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of drug concentrations in plasma by characterizing PK parameters (AUC) | ||
| Assessment of drug concentrations in plasma by characterizing PK parameters (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sostek, MD | AstraZeneca | Study Director |
| Shunji Matsuki, MD | Kyusyu Clinical Phramacology Research Clinic | Principal Investigator |
| Yukiya Sasaki, MD | AstraZeneca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chūōku | Fukuoka | Japan |
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| ID | Term |
|---|---|
| C000589308 | naloxegol |
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| Drug |
Tablet, Oral, Once daily |
|