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The is an assessment of Relative Bioavailability of NKTR-118 in Three Formulations in Healthy Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NKTR118 Formulation 1 | Experimental | Fasted |
|
| NKTR118 Formulation 2 | Experimental | Fasted |
|
| NKTR118 Formulation 3 | Experimental | Fasted |
|
| NKTR118 Formulation 1a | Experimental | Fed |
|
| NKTR118 Formulation 3a | Experimental | FED |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKTR118 Formulation 1 | Drug | Oral dose, 25 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of (Cmax) | day-1 to day 3 | |
| Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of time to Cmax (tmax) | day-1 to day 3 | |
| Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of half-life (t1/2λz) | day-1 to day 3 | |
| Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area under concentration-time curve (AUC(0-t)) | day-1 to day 3 | |
| Pharmacokinetics after a dose of NKTR-118 25 mg by assessment of area from time zero (pre-dose) extrapolated to infinity (AUC). | day-1 to day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing adverse events | Duration day -1 (Visit 2) to follow up (Visit 12) | |
| Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Safety Laboratory values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sostek, MD | AstraZeneca | Study Director |
| David Mathews, MD | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| Label | URL |
|---|---|
| D3820C00025 Clinical Study Report Synopsis | View source |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| NKTR118 Formulation 2 |
| Drug |
Oral dose, 25 mg |
|
| NKTR118 Formulation 3 | Drug | Oral dose, 25 mg |
|
| NKTR118 Formulation 1a | Drug | Oral dose, 25 mg |
|
| NKTR118 Formulation 3a | Drug | Oral dose, 25 mg |
|
| Duration day -1 (Visit 2) to follow up (Visit 12) |
| Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing 12-Lead Electrocardiograms | Duration day -1 (Visit 2) to follow up (Visit 12) |
| Safety and tolerability of NKTR-118 following administration of a single oral doses of NKTR-118 of 3 different formulations during fed and fasted conditions by assessing Columbia-Suicide Severity Rating Scale (C-SSRS) | Duration day -1 (Visit 2) to follow up (Visit 12) |
| Concentration of NKTR-118 in plasma samples after drug intake during Fed condition | Duration: Day 1 to day 4 at the 2 last inhouse stays |