Clinical trial NCT02025348: Explore the Performance of IntelliCap.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Plasma Concentration
Pharmacokinetic Profile
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-01-01
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: In vivo performance
timeFrame: 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 outcomes:
measure: Pharmacokinetic parameters
timeFrame: 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 outcomes:
measure: Safety
timeFrame: At the end of study, approximately 8 weeks after recruitment.
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Simbec Research
name: Salvatore Febbraro, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: