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The purpose of this study is to assess the pharmacokinetics of NKTR-118 in patients with impaired hepatic function versus subjects with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Normal hepatic function, 25 mg NKTR-118 administered orally |
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| Group 2 | Experimental | Mild hepatic impairment, 25 mg NKTR-118 administered orally |
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| Group 3 | Experimental | Moderate hepatic impairment, 25 mg NKTR-118 administered orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKTR-118 | Drug | 25 mg Oral tablets, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax) | Duration from predose day 1 to day 6. |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting adverse events. | Duration from day -1 to follow up. ( Approximately 15-18 days) | |
| To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function and in subjects with normal hepatic function by collecting vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sostek, MD | AstraZeneca | Study Director |
| Thomas Marbury, MD | Orlando Clinical Research Center | Principal Investigator |
| Bo Fransson, MD | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24945932 | Derived | Bui K, She F, Sostek M. The effects of mild or moderate hepatic impairment on the pharmacokinetics, safety, and tolerability of naloxegol. J Clin Pharmacol. 2014 Dec;54(12):1368-74. doi: 10.1002/jcph.348. Epub 2014 Jun 27. |
| Label | URL |
|---|---|
| D3820C00010 Clinical Study Report Synopsis.pdf | View source |
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| ID | Term |
|---|---|
| C000589308 | naloxegol |
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| Duration from day -1 to follow up. ( Approximately 15-18 days) |
| To examine the safety and tolerability of a single oral dose of 25 mg NKTR-118 in patients with impaired hepatic function by collecting safety blood samples | Duration from day -1 to follow up. ( Approximately 15-18 days) |