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The purpose of this study is to evaluate the effects on QTc interval in healthy males when administered a single dose of NKTR-118 compared with placebo and moxifloxacin. (QTc is a specific time interval that can be measured in a heart beat by taking Electrocardiogram (ECG))
A Single Center, Randomized, Double-blinded, Placebo-controlled, Open-label, Positive-controlled, Four-way Crossover Study to Assess the Effect of a Single Oral Dose NKTR-118 Administration on QTc Interval Compared to Placebo, Using AVELOX (moxifloxacin) as a Positive Control, in Healthy Male Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | NKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets) |
|
| B | Experimental | NKTR-118 150 mg (6x25 mg tablet) |
|
| C | Placebo Comparator | NKTR-118 placebo (6x placebo tablets) |
|
| D | Active Comparator | Moxifloxacin (1 x 400 mg tablet) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NKTR-118 | Drug | 25 mg tablet |
| |
| moxifloxacin |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of a single dose of NKTR-118 25 mg and 150 mg on the change in time-matched QTcF intervals compared with placebo | 30 days pre-dose through 4 treatment periods and follow up 71 days post dose. | |
| The effect of a single dose of NKTR-118 25 mg and 150 mg on the change in time-matched QTcF intervals compared with placebo | Follow up 71 days post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of a single oral dose of moxifloxacin 400 mg on the changes in time-match QTcF intervals compared with placebo, which will be used as supporting data. | 30 days pre-dose through 4 treatment periods | |
| Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150 mg in healthy male subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sostek, MD | AstraZeneca, Wilmington US | Study Director |
| David Matthews, MD | Quintiles, Overland Park Kansas US | Principal Investigator |
| Emilie Ramos, MD | AstraZeneca, Alderley Park, UK | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24238792 | Derived | Gottfridsson C, Carlson G, Lappalainen J, Sostek M. Evaluation of the effect of Naloxegol on cardiac repolarization: a randomized, placebo- and positive-controlled crossover thorough QT/QTc study in healthy volunteers. Clin Ther. 2013 Dec;35(12):1876-83. doi: 10.1016/j.clinthera.2013.09.019. Epub 2013 Nov 13. |
| Label | URL |
|---|---|
| D3820C00014 Clinical Study Report Synopsis | View source |
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| Drug |
400 mg tablet |
|
| Placebo | Drug | tablet |
|
| 30 days pre-dose through 4 treatment periods |
| To evaluate the effect of a single oral dose of moxifloxacin 400 mg on the changes in time-match QTcF intervals compared with placebo, which will be used as supporting data. | Follow up 71 days post dose |
| Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150mg in healthy male subjects. | Follow up 71 days post dose. |
| ID | Term |
|---|---|
| C000589308 | naloxegol |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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