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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01325415
First received: March 28, 2011
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

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))


Condition Intervention Phase
Amount of NKTR-118 in Blood
Variation in the Heart's Electrical Cycle
Drug: NKTR-118
Drug: moxifloxacin
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 30 days pre-dose through 4 treatment periods ] [ Designated as safety issue: Yes ]
  • Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150 mg in healthy male subjects. [ Time Frame: 30 days pre-dose through 4 treatment periods ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: Follow up 71 days post dose ] [ Designated as safety issue: Yes ]
  • Collect adverse events to assess the safety after dosing of NKTR-118 25mg and 150mg in healthy male subjects. [ Time Frame: Follow up 71 days post dose. ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
NKTR-118 25 mg (1x25 mg tablet + 5x placebo tablets)
Drug: NKTR-118
25 mg tablet
Drug: Placebo
tablet
Experimental: B
NKTR-118 150 mg (6x25 mg tablet)
Drug: NKTR-118
25 mg tablet
Drug: Placebo
tablet
Placebo Comparator: C
NKTR-118 placebo (6x placebo tablets)
Drug: Placebo
tablet
Active Comparator: D
Moxifloxacin (1 x 400 mg tablet)
Drug: moxifloxacin
400 mg tablet

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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325415

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mark Sostek, MD AstraZeneca, Wilmington US
Principal Investigator: David Matthews, MD Quintiles, Overland Park Kansas US
Study Chair: Emilie Ramos, MD AstraZeneca, Alderley Park, UK
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mark Sostek / Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01325415     History of Changes
Other Study ID Numbers: D3820C00014
Study First Received: March 28, 2011
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase 1
healthy male volunteers
cross-over study
NKTR-118

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014