Explore the Performance of IntelliCap.

January 26, 2016 updated by: AstraZeneca

A Randomised, Open-label, 4-way Crossover Study in Healthy Subjects to Explore the Performance of IntelliCap® by Comparing Pharmacokinetic Profiles of a Probe Drug.

This is an open-label, randomised, 4-way crossover study in twelve healthy male volunteers.

The study will characterise the performance of IntelliCap® by evaluating the plasma concentration and pharmacokinetic profile of a probe drug (IMP; metoprolol) released from IntelliCap® with three different release profiles and the plasma concentration and pharmacokinetic profile of the same probe drug after a single dose of an oral solution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male volunteers aged between 18 and 50 years of age, inclusive.
  • Subjects with a body weight of at least 50 kg and no more than 100 kg, inclusive.
  • Subjects with a body mass index (BMI) of 18 - 30 kg/m2, inclusive. BMI = Body weight (kg) / [Height (m)]2.
  • Subjects with suitable veins for cannulation or repeated venepuncture.
  • Subjects must be available to complete the study.
  • Subjects must satisfy a medical examiner about their fitness to participate in the study.
  • Subjects must provide written informed consent to participate in the study.

Exclusion Criteria:

  • History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
  • Abnormal vital signs, after 10 min supine rest, defined as any of the following:
  • Systolic blood pressure < 100 mmHg or ≥ 140 mmHg.
  • Diastolic blood pressure < 50 mmHg or ≥ 90 mmHg.
  • Heart rate < 50 or > 85 beats per minute.
  • Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG.

  • History of severe allergy/hypersensitivity or on-going clinically important allergy/ hypersensitivity as judged by the Investigator or known hypersensitivity to metoprolol (including other beta-blockers) or any other component of the product.

    •Plasma donation within one month of screening or any blood donation/blood loss greater than 500 mL during the three (3) months prior to screening.

  • Receipt of a new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that includes drug treatment within at least three (3) months of the first administration of study treatment in this study. The period of exclusion begins three months after the final dose. Note: subjects consented and screened, but not randomised in this study or a previous phase I study, are not excluded.
  • Previous randomisation to treatment in the present study.
  • Involvement of any CRO/third party contractor or AZ employee and their close relatives regardless of their role.
  • Judgement by the Investigator that the subject should not participate in the study if they have any on-going or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.
  • Subjects who cannot communicate reliably with the Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A metoprolol 50mg
IntelliCap® capsule Release profile 1 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg).
Drug: IntelliCap
Drug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule.
Other Names:
  • IntelliCap and metoprolol
Experimental: Treatment B metoprolol 50mg
IntelliCap® capsule Release profile 2 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg).
Drug: IntelliCap
Drug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule.
Other Names:
  • IntelliCap and metoprolol
Experimental: Treatment C metoprolol 50mg
IntelliCap® capsule Release profile 3 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg).
Drug: IntelliCap
Drug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule.
Other Names:
  • IntelliCap and metoprolol
Experimental: Treatment D metorpolol 50mg
metoprolol oral solution 1 mg/mL (dose 50 mg).
Drug: IntelliCap
Drug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule.
Other Names:
  • IntelliCap and metoprolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In vivo performance
Time Frame: Pre-dose, pre-actuation (except in study period when subjects are dosed with oral solution) , 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 14 h, 24 h, 28 h, and 32 h
To assess the in vivo performance of the IntelliCap® system by characterizing the plasma concentration of a probe drug (metoprolol)
Pre-dose, pre-actuation (except in study period when subjects are dosed with oral solution) , 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 14 h, 24 h, 28 h, and 32 h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters
Time Frame: Pre-dose, pre-actuation (except in study period when subjects are dosed with oral solution) , 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 14 h, 24 h, 28 h, and 32 h.
To determine the pharmacokinetic parameters of a probe drug (metoprolol), by assessment of AUC0-t, AUC0-∞, Cmax, tmax, t1/2 and Vz/F.
Pre-dose, pre-actuation (except in study period when subjects are dosed with oral solution) , 0.5 h, 1 h, 1.5 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 8 h, 10 h, 12 h, 14 h, 24 h, 28 h, and 32 h.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: At the end of study, approximately 8 weeks after recruitment.
Incidence of adverse events.
At the end of study, approximately 8 weeks after recruitment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Salvatore Febbraro, MD PhD, Simbec Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

December 30, 2013

First Posted (Estimate)

January 1, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1840M00044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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