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This study will be assessing the pharmacokinetics of NKTR-118 in subjects with renal impairment compared to that in subjects with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NKTR118 Group1 | Experimental | Normal Renal Function |
|
| NKTR118 Group 2 | Experimental | Moderate Renal Function |
|
| NKTR118 Group 3 | Experimental | Severe Renal Impairment |
|
| NKTR118 Group 4 | Experimental | End-Stage Renal Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKTR118 Group1 | Drug | Oral dose, 25 mg |
| |
| NKTR118 Group 2 |
| 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) | Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis) | PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose. |
| To assess the pharmacokinetics of a single dose of NKTR-118 25 mg by assessment of maximum concentration (Cmax) | Groups 1 (normal), 2 (moderate), 3 (severe), and for Group 4 (End-stage renal disease requiring hemodialysis) | PK blood samples will be collected in treatment periods 1 and 2 at predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 and 72 h post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing Adverse events. | Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment | |
| To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing vital signs |
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Inclusion Criteria:
Male subjects who are sexually active must be willing to use a barrier method of contraception (condom). Women must be of non-childbearing potential or, if of childbearing potential, must have a negative pregnancy test (at screening and at each admission) and be using a highly effective form of birth control for 3 months before enrollment and be willing to use a highly effective form of birth control during the study and until 3 months after their last dose of IP.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sostek, MD | AstraZeneca | Study Director |
| Thomas Marbury, MD | Orlando Clinical Research Center US | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Anaheim | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24946021 | Derived | Bui K, She F, Sostek M. The effects of renal impairment on the pharmacokinetics, safety, and tolerability of naloxegol. J Clin Pharmacol. 2014 Dec;54(12):1375-82. doi: 10.1002/jcph.349. Epub 2014 Jul 1. |
| Label | URL |
|---|---|
| D3820C00009 Clinical Study Report Synopsis | View source |
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| Drug |
Oral dose, 25 mg |
|
| NKTR118 Group3 | Drug | Oral dose, 25 mg |
|
| NKTR118 | Drug | Oral dose, 25 mg |
|
| Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment |
| To assess the safety and tolerability of NKTR-118 in subjects with renal impairment and normal renal function by assessing safety blood samples | Duration Day -1 to follow-up at either visit 3 or 6 dependant on treatment |
| Orlando |
| Florida |
| United States |
| Research Site | Overland Park | Kansas | United States |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000589308 | naloxegol |
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