NCT01318655

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2011

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

Study Start

First participant enrolled

March 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
4 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

August 25, 2011

Status Verified

August 1, 2011

Enrollment Period

4 months

First QC Date

March 17, 2011

Last Update Submit

August 24, 2011

Conditions

Healthy

Keywords

Phase IJapanSADMAD

Outcome Measures

Primary Outcomes (1)

  • Investigate the safety and tolerability of NKTR-118 using incidence of Adverse Events

Secondary Outcomes (2)

  • Assessment of drug concentrations in plasma by characterizing PK parameters (AUC)

  • Assessment of drug concentrations in plasma by characterizing PK parameters (Cmax)

Study Arms (2)

NKTR-118

EXPERIMENTAL
Drug: NKTR-118

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

NKTR-118DRUG

Tablet, Oral, Once daily

NKTR-118
PlaceboDRUG

Tablet, Oral, Once daily

Placebo

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Years to 45 Years, 65 Years to 80 Years
  • Body mass index (BMI): 18 to 27 kg/m
  • Male subjects should be willing to use barrier contraception ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
  • Non-smokers or ex-smokers (not smoked in the past 3 months).

You may not qualify if:

  • Clinically relevant disease and/or abnormalities (past or present)
  • Clinically relevant abnormalities in physical examinations,vital signs,clinical chemistry, hematology or urinalysis as judged by the investigator
  • Use of any prescribed or non-prescribed medication including herbal remedies, vitamins and minerals during the two weeks prior to the first administration of investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Chūōku, Fukuoka, Japan

Location

MeSH Terms

Interventions

naloxegol

Study Officials

  • Mark Sostek, MD

    AstraZeneca

    STUDY DIRECTOR

  • Shunji Matsuki, MD

    Kyusyu Clinical Phramacology Research Clinic

    PRINCIPAL INVESTIGATOR

  • Yukiya Sasaki, MD

    AstraZeneca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 18, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 25, 2011

Record last verified: 2011-08

Locations

JP(1)