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OpenTrials
Completed

NCT Number: NCT02025348

Explore the Performance of IntelliCap.

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Research Site

Merthyr Tydfil, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

IntelliCap

Drug

Drug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule.

Other names: IntelliCap and metoprolol

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

Other outcomes

  1. Safety

    Time frame: At the end of study, approximately 8 weeks after recruitment.

    Incidence of adverse events.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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.

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 1, 2014
Registry last updated
Jan 27, 2016

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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