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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief Summary
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
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
A
NKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets)
Intervention: NKTR-118 (Drug)
A
NKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets)
Intervention: Placebo (Drug)
B
NKTR-118 150 mg (6x25 mg tablet)
Intervention: NKTR-118 (Drug)
B
NKTR-118 150 mg (6x25 mg tablet)
Intervention: Placebo (Drug)
C
NKTR-118 placebo (6x placebo tablets)
Intervention: Placebo (Drug)
D
Moxifloxacin (1 x 400 mg tablet)
Intervention: moxifloxacin (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 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
Time Frame: Follow up 71 days post dose.
Secondary Outcomes
- 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 150 mg in healthy male subjects.(30 days pre-dose through 4 treatment periods)
- 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.)