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

AstraZeneca

Status and phase: Completed; Phase 1

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

Treatments: Drug: NKTR-118; Drug: Placebo; Drug: moxifloxacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01325415

D3820C00014

Details and patient eligibility

About

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))

Full 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

Enrollment: 45 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

NKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets)

Treatment:

Drug: NKTR-118

Drug: Placebo

B

Experimental group

Description:

NKTR-118 150 mg (6x25 mg tablet)

Treatment:

Drug: NKTR-118

Drug: Placebo

C

Placebo Comparator group

Description:

NKTR-118 placebo (6x placebo tablets)

Treatment:

Drug: Placebo

D

Active Comparator group

Description:

Moxifloxacin (1 x 400 mg tablet)

Treatment:

Drug: moxifloxacin