NCT01623609

Brief Summary

The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2012

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

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 15, 2014

Status Verified

October 1, 2014

Enrollment Period

2 months

First QC Date

June 18, 2012

Last Update Submit

October 13, 2014

Conditions

Opioid Induced Constipation

Keywords

Phase 1Healthy volunteersNaloxegolBioequivalence

Outcome Measures

Primary Outcomes (1)

  • Description of the pharmacokinetic (PK) profile for naloxegol in terms of maximum observed plasma concentration (Cmax) and area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC) for each treatment period.

    Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours

Secondary Outcomes (5)

  • Description of the safety profile in terms of adverse events, clinical laboratory assessments , vital signs (blood pressure and pulse rate), physical examinations, electrocardiograms, and Columbia-Suicide Severity Rating scale (CSSRS)

    From baseline day 1 through to Follow-up (Maximum 40 days)

  • Description of the pharmacokinetic(PK) profile for naloxegol in terms of time to Cmax (tmax), terminal half-life (t1/2λz), terminal rate constant (λz). For each treatment period

    Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours

  • Description of the pharmacokinetic (PK) profile for naloxegol in terms of area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)].For each treatment period

    Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours

  • Description of the pharmacokinetic (PK) profile for naloxegol in terms of area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)], apparent oral clearance from plasma (CL/F).For each treatment period

    Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours

  • Description of the pharmacokinetic (PK) profile for naloxegol in terms of apparent volume of distribution during the terminal phase (Vz/F)For each treatment period

    Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours

Study Arms (3)

A

EXPERIMENTAL

Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fasted conditions

Drug: Naloxegol

B

EXPERIMENTAL

Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fed conditions

Drug: Naloxegol

C

EXPERIMENTAL

Naloxegol film-coated IR tablet 25 mg Phase III formulation under fasted conditions

Drug: Naloxegol

Interventions

NaloxegolDRUG

Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation

AB

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female non-pregnant, non-lactating.
  • Volunteers with suitable veins for cannulation or repeated venipuncture.
  • Male healthy volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the investigational product.
  • The female partner should use contraception during this period.

You may not qualify if:

  • History of any clinically significant disease or disorder.
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.
  • Volunteers who have smoked or used nicotine products within the previous 3 months from the date of screening.
  • Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the Investigator .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

London, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

naloxegol

Condition Hierarchy (Ancestors)

ConstipationSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Mark Sostek, MD

    Astrazeneca Wilmington, US

    STUDY DIRECTOR

  • Arpeat Kaviya, MBCHB, MRCP

    Quintiles London UK

    PRINCIPAL INVESTIGATOR

  • Bo Fransson, MD

    Astrazeneca Sodertalje Sweden

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 15, 2014

Record last verified: 2014-10

Locations

GB(1)