Research Site
Merthyr Tydfil, United Kingdom
NCT Number: NCT02025348
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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Notify Me18 year–50 year
Male
Interventional
Early Phase 1
Merthyr Tydfil, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
•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.
Drug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule.
Other names: IntelliCap and metoprolol
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)
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.
Time frame: At the end of study, approximately 8 weeks after recruitment.
Incidence of adverse events.
AstraZeneca
Industry
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.
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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