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Study to Assess the Absorption, Metabolism and Excretion of [14C] NKTR-118 after a Single-Dose Oral Administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] NKTR-118 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] NKTR-118 | Drug | Single 25 mg oral dose administered on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of radioactive dose recovered in urine and feces samples and the total percentage of radioactive dose recovered in both urine and feces | Range of Day 1 until day 10 | |
| Concentration of total radioactivity in blood and plasma samples | Range of Day 1 until day 10 | |
| Concentration of NKTR-118 in blood and plasma sample | Range of Day 1 until day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing adverse event | Range of Day -1 until follow up visit (Visit 3) | |
| Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing vital signs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Kasti, MD | Quintiles, Inc. | Principal Investigator |
| Mark Sostek, PhD | AstraZeneca | Study Director |
| Emeline Ramos | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| Label | URL |
|---|---|
| Clinical Study Report Synopsis | View source |
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| ID | Term |
|---|---|
| C000589308 | naloxegol |
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| Range of Day -1 until follow up visit (Visit 3) |
| Safety and tolerability of NKTR-118 following administration of a single oral dose of [14] NKTR-118 solution by assessing safety blood samples | Range of Day -1 until follow up visit (Visit 3) |