NCT01325415

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))

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

3 months

First QC Date

March 28, 2011

Last Update Submit

October 13, 2014

Conditions

Amount of NKTR-118 in BloodVariation in the Heart's Electrical Cycle

Keywords

Phase 1healthy male volunteerscross-over studyNKTR-118

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

  • 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 150mg in healthy male subjects.

    Follow up 71 days post dose.

Study Arms (4)

A

EXPERIMENTAL

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

Drug: NKTR-118Drug: Placebo

B

EXPERIMENTAL

NKTR-118 150 mg (6x25 mg tablet)

Drug: NKTR-118Drug: Placebo

C

PLACEBO COMPARATOR

NKTR-118 placebo (6x placebo tablets)

Drug: Placebo

D

ACTIVE COMPARATOR

Moxifloxacin (1 x 400 mg tablet)

Drug: moxifloxacin

Interventions

NKTR-118DRUG

25 mg tablet

AB
moxifloxacinDRUG

400 mg tablet

D
PlaceboDRUG

tablet

ABC

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Overland Park, Kansas, United States

Location

Related Publications (1)

  • Gottfridsson C, Carlson G, Lappalainen J, Sostek M. Evaluation of the effect of Naloxegol on cardiac repolarization: a randomized, placebo- and positive-controlled crossover thorough QT/QTc study in healthy volunteers. Clin Ther. 2013 Dec;35(12):1876-83. doi: 10.1016/j.clinthera.2013.09.019. Epub 2013 Nov 13.

    PMID: 24238792DERIVED

Related Links

MeSH Terms

Interventions

naloxegolMoxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mark Sostek, MD

    AstraZeneca, Wilmington US

    STUDY DIRECTOR

  • David Matthews, MD

    Quintiles, Overland Park Kansas US

    PRINCIPAL INVESTIGATOR

  • Emilie Ramos, MD

    AstraZeneca, Alderley Park, UK

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 29, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

US(1)