Explore the performance of IntelliCap.

Study identifier:D1840M00044

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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.

Medical condition

Plasma concentration

Phase

N/A

Healthy volunteers

Yes

Study drug

IntelliCap

Sex

Male

Actual Enrollment

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Jan 2014

Primary Completion Date: 01 Mar 2014

Study Completion Date: 01 Mar 2014

Study design

Allocation: Randomized
Endpoint Classification: N/A
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Jan 2016 by AstraZeneca

Collaborators

Inclusion and exclusion 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.

No locations available

Arms	Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: IntelliCap and metoprolol

Documents available

D1840M00044_CSR_Synopsis
Download
Publication
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Salvatore Febbraro

Simbec Research Limited