Clinical trial NCT01623609: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid Induced Constipation
Keywords: Phase 1
Healthy volunteers
Naloxegol
Bioequivalence
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-06-20
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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 .

Primary outcomes:
measure: 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.
timeFrame: Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
Secondary outcomes:
measure: 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)
timeFrame: From baseline day 1 through to Follow-up (Maximum 40 days)
measure: 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
timeFrame: Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
measure: 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
timeFrame: Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
measure: 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
timeFrame: Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
measure: 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
timeFrame: Predose,0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, and 48 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Astrazeneca Wilmington, US
name: Mark Sostek, MD
role: STUDY_DIRECTOR
affiliation: Quintiles London UK
name: Arpeat Kaviya, MBCHB, MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Astrazeneca Sodertalje Sweden
name: Bo Fransson, MD
role: STUDY_CHAIR
References: