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Completed

NCT Number: NCT01623609

Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol

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

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Key information

Conditions

Opioid Induced Constipation Chemically-Induced Disorders Constipation Mental Disorders Narcotic-Related Disorders Opioid-Induced Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Naloxegol

Drug

Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation

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.

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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 20, 2012
Registry last updated
Oct 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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