Clinical Pharmacology Unit
Merksem, 2170, Belgium
NCT Number: NCT04225078
The purpose of this study is to assess the effects of loperamide on QT/ QT interval corrected for heart rate (QTc) intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic exposures in healthy participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Merksem, 2170, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Loperamide will be administered as a single oral dose at the expected therapeutic or supratherapeutic doses respectively.
Matching loperamide placebo capsules will be administered orally.
Moxifloxacin tablets will be administered orally.
Time frame: Baseline up to 9 weeks
Change from baseline in QTc intervals for loperamide at therapeutic and supratherapeutic doses will be reported.
Time frame: Up to 9 weeks
The percentage of participants in each treatment having T-wave morphology changes from baseline that represent the appearance or worsening of the morphological abnormality will be reported.
Time frame: Up to 9 weeks
The percentage of participants with the occurrence of abnormal U-waves morphology that represent the appearance or worsening of the morphological abnormality will be reported.
Time frame: Up to 9 weeks
Cmax is defined as the maximum observed plasma concentration.
Time frame: Up to 9 weeks
Tmax is defined as the time to reach the maximum observed plasma concentration.
Time frame: Up to 9 weeks
AUC (0-last) is defined as the area under the plasma concentration-time curve from the time of dosing to the last measurable plasma concentration.
Time frame: Up to 9 weeks
(AUC[0-inifinity]) is defined as the area under the plasma concentration-time curve from time zero to infinity, calculated as AUClast+Clast/lambda (z), where Clast is the last observed measurable concentration.
Time frame: Up to 9 weeks
Lambda (z) is defined as the apparent terminal elimination rate constant, estimated by linear regression using the terminal log-linear phase of the log-transformed concentration versus time curve.
Time frame: Up to 9 weeks
t1/2 is defined as the apparent elimination half-life associated with the terminal slope lambda (z) of the semilogarithmic drug concentration-time curve.
Time frame: Up to 9 weeks
M/p ratio is defined as metabolite to parent ratio (M/P) for (AUC[0-inifinity]) corrected for molecular weight using the following molecular weights: loperamide 477.045 gram per mol (g/mol), M1 463.018 g/mol.
Time frame: Up to 9 weeks
The relationship between systemic plasma concentrations of loperamide and change in QT/QTc will be reported.
Time frame: Up to 9 Weeks
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Janssen Research & Development, LLC
Industry
A Randomized, Double-blind, Placebo- and Positive-controlled, Single-dose, 4 Way Crossover Study to Evaluate the Effects of Loperamide (JNJ-289679) on Electrocardiogram Intervals in Healthy Adult Subjects
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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