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

Phase 1

Completed

• Conditions: Amount of NKTR-118 in Blood; Variation in the Heart's Electrical Cycle
• Interventions: Drug: NKTR-118; Drug: moxifloxacin; Drug: Placebo

• Registration Number: NCT01325415
• Lead Sponsor: AstraZeneca

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 Timeline

• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Study Start: 2011-04
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-13
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	NKTR-118	NKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets)
A	Placebo	NKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets)
B	Placebo	NKTR-118 150 mg (6x25 mg tablet)
C	Placebo	NKTR-118 placebo (6x placebo tablets)
B	NKTR-118	NKTR-118 150 mg (6x25 mg tablet)
D	moxifloxacin	Moxifloxacin (1 x 400 mg tablet)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States