Back to resultsOpen Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
Primary Purpose
Opioid Induced Constipation
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Naloxegol
Naloxegol
Sponsored by
About this trial
This is an interventional basic science trial for Opioid Induced Constipation focused on measuring Phase 1, Healthy volunteers, Naloxegol, Bioequivalence
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 .
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
A
B
C
Arm Description
Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fasted conditions
Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fed conditions
Naloxegol film-coated IR tablet 25 mg Phase III formulation under fasted conditions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01623609
Brief Title
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
Official Title
A Phase I, Randomised, Open-label, 3 Way Cross-over Study in Healthy Volunteers to Demonstrate the Bioequivalence of the Naloxegol 25 mg Commercial and Phase III Formulations and to Assess the Effect of Food Administration on the Pharmacokinetics of the Commercial Formulation.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.
Detailed Description
A Phase I, Randomised, Open-label, 3 way Cross-over Study in Healthy Volunteers to Demonstrate the Bioequivalence of the Naloxegol 25 mg Commercial and Phase III Formulations and to Assess the Effect of Food Administration on the Pharmacokinetics of the Commercial Formulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Induced Constipation
Keywords
Phase 1, Healthy volunteers, Naloxegol, Bioequivalence
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fasted conditions
Arm Title
B
Arm Type
Experimental
Arm Description
Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fed conditions
Arm Title
C
Arm Type
Experimental
Arm Description
Naloxegol film-coated IR tablet 25 mg Phase III formulation under fasted conditions
Intervention Type
Drug
Intervention Name(s)
Naloxegol
Intervention Description
Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation
Intervention Type
Drug
Intervention Name(s)
Naloxegol
Intervention Description
Naloxegol film-coated Phase III formulation 25 mg film-coated IR tablet
Primary Outcome Measure Information:
Title
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.
Time Frame
Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
Secondary Outcome Measure Information:
Title
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)
Time Frame
From baseline day 1 through to Follow-up (Maximum 40 days)
Title
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
Time Frame
Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
Title
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
Time Frame
Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
Title
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
Time Frame
Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
Title
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
Time Frame
Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Sostek, MD
Organizational Affiliation
Astrazeneca Wilmington, US
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Arpeat Kaviya, MBCHB, MRCP
Organizational Affiliation
Quintiles London UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bo Fransson, MD
Organizational Affiliation
Astrazeneca Sodertalje Sweden
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1397&filename=Clinical_Study_Report_Synopsis_D3820C00018.pdf
Description
Clinical_Study_Report_Synopsis_D3820C00018
Learn more about this trial
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
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