Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol

Opioid Induced Constipation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623609
• Other study ID #: D3820C00018
• Status: Completed
• Phase: Phase 1
• First received: June 18, 2012
• Last updated: October 13, 2014
• Start date: July 2012
• Est. completion date: September 2012

Study information

• Verified date: October 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUK: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 .

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Constipation
• Opioid Induced Constipation

Intervention

Drug:
• Naloxegol
Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation
• Naloxegol
Naloxegol film-coated Phase III formulation 25 mg film-coated IR tablet

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	Yes
Secondary	Description of the pharmacokinetic(PK) profile for naloxegol in terms of time to Cmax (tmax), terminal half-life (t1/2?z), terminal rate constant (?z). 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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Clinical_Study_Report_Synopsis_D3820C00018