Explore the Performance of IntelliCap.

Plasma Concentration Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025348
• Other study ID #: D1840M00044
• Status: Completed
• Phase: Phase 0
• First received: December 20, 2013
• Last updated: January 26, 2016
• Start date: January 2014
• Est. completion date: March 2014

Study information

• Verified date: January 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetic Profile
• Plasma Concentration

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Research Site	Merthyr Tydfil

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	Incidence of adverse events.	At the end of study, approximately 8 weeks after recruitment.	Yes
Primary	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	No
Secondary	Pharmacokinetic parameters	To determine the pharmacokinetic parameters of a probe drug (metoprolol), by assessment of AUC0-t, AUC0-8, 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.	No

External Links

•   D1840M00044_CSR_Synopsis
•   Publication