Amount of NKTR-118 in Blood, Variation in the Heart's Electrical Cycle
Conditions
Keywords
Phase 1, healthy male volunteers, cross-over study, NKTR-118
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
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
| 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. |
Countries
United States
Outcome results
None listed