Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Opioid Induced Constipation

Intervention / Treatment
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* Drug: Naloxegol
* Drug: Naloxegol


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fasted conditions | Drug: Naloxegol<br>* Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation<br>|
| Experimental: B<br>Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fed conditions | Drug: Naloxegol<br>* Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation<br>|
| Experimental: C<br>Naloxegol film-coated IR tablet 25 mg Phase III formulation under fasted conditions | Drug: Naloxegol<br>* Naloxegol film-coated Phase III formulation 25 mg film-coated IR tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, Healthy volunteers, Naloxegol, Bioequivalence