A Placebo-controlled Four Way Crossover Study to Asses the Effect of a Single Oral Dose of NKTR-118 on QTc Interval in Healthy Male Subjects

Study Overview
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Brief Summary
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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))

Detailed Description
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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

Official Title
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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

Conditions
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Amount of NKTR-118 in Blood, Variation in the Heart's Electrical Cycle

Intervention / Treatment
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* Drug: NKTR-118
* Drug: moxifloxacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venipuncture. Body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weight at least 50 kg but no more than 100 kg. Exclusion Criteria: Clinically significant medical history including severe allergies or a history of mental disorders or any cardiac history, history or presence of gastrointestinal, hepatic, or renal disease. Abnormal heart rhythm including any abnormal arrhythmias, marked sinus arrhythmias, or junctional rhythms. Known or suspected history of drug abuse, current smokers or those who have smoked and/or used nicotine products within 3 months prior to enrollment. Excessive intake of caffeine-containing products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>NKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets) | Drug: NKTR-118<br>* 25 mg tablet<br>Drug: Placebo<br>* tablet<br>|
| Experimental: B<br>NKTR-118 150 mg (6x25 mg tablet) | Drug: NKTR-118<br>* 25 mg tablet<br>Drug: Placebo<br>* tablet<br>|
| Placebo Comparator: C<br>NKTR-118 placebo (6x placebo tablets) | Drug: Placebo<br>* tablet<br>|
| Active Comparator: D<br>Moxifloxacin (1 x 400 mg tablet) | Drug: moxifloxacin<br>* 400 mg tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, healthy male volunteers, cross-over study, NKTR-118