Explore the Performance of IntelliCap.

NCT02025348 | Completed Early Phase 1

• 1 other identifier: D1840M00044
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Plasma Concentration; Pharmacokinetic Profile

Outcome Measures

Primary Outcomes (1)

• In vivo performance

  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 Outcomes (1)

• Pharmacokinetic parameters

  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 (1)

• Safety

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

Study Arms (4)

Treatment A metoprolol 50mg

EXPERIMENTAL

IntelliCap® capsule Release profile 1 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg).

Drug: IntelliCap

Treatment B metoprolol 50mg

EXPERIMENTAL

IntelliCap® capsule Release profile 2 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg).

Drug: IntelliCap

Treatment C metoprolol 50mg

EXPERIMENTAL

IntelliCap® capsule Release profile 3 filled with metoprolol gastroenteral solution 233 mg/mL (dose 50 mg).

Drug: IntelliCap

Treatment D metorpolol 50mg

EXPERIMENTAL

metoprolol oral solution 1 mg/mL (dose 50 mg).

Drug: IntelliCap

Interventions

IntelliCap DRUG

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

Also known as: IntelliCap and metoprolol

Treatment A metoprolol 50mg; Treatment B metoprolol 50mg; Treatment C metoprolol 50mg; Treatment D metorpolol 50mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Merthyr Tydfil, United Kingdom

Location

Related Links

• D1840M00044\_CSR\_Synopsis
• Publication

MeSH Terms

Interventions

Metoprolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Salvatore Febbraro, MD PhD

  Simbec Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: January 1, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

GB (1)