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- Klinische proef NCT04225078
A Study to Evaluate the Effects of Loperamide (JNJ-289679) on Electrocardiogram Intervals in Healthy Adult Participants
26 april 2022 bijgewerkt door: Janssen Research & Development, LLC
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
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
66
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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-
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Merksem, België, 2170
- Clinical Pharmacology Unit
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 55 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- All female participants, except if postmenopausal, must have a negative serum beta-human chorionic gonadotropin (beta hCG) pregnancy test at screening and a negative urine pregnancy test on Day 1 of each treatment period
- A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 1 month after the last study drug administration
- A male participant, who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (example, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Must have a body mass index (body mass index [BMI]; weight kilogram per meter per height per square per meter square [kg/height^2 m^2]) between 18.0 and 30.0 kg/m^2 (inclusive) with a body weight not lower than 50 kilogram (kg)
- Must have a blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of Mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. Heart rate between 45 and 100 beats per minute (bpm), inclusive
Exclusion Criteria:
- History of or current renal insufficiency (estimated glomerular filtration rate [eGFR] less than (<) 90 milliliter per minute per meter square (mL/min/1.73m^2) based on the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula at screening only)
- Clinically significant abnormal values for hematology, serum chemistry (including thyroid-stimulating hormone [TSH] at screening only) or urinalysis at screening or at admission to the study site, as deemed appropriate by the investigator. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable
- Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or at admission to the study site as deemed appropriate by the investigator
- Received a known inhibitor of Cytochrome (CY) P3A4, CYP3A4, CYP2C8, or P-glycoprotein (P-gp) activity within 14 days or a period less than 5 times the drugs' half-life; whichever is longer, before the first dose of the study drug is scheduled
- Received a known inducer of CYP3A4 or CYP2C8 activity within 28 days before the first dose of the study drug is scheduled
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Treatment Sequence 1: Treatment ADBC
Participants will receive treatment A (Loperamide therapeutic dose) on Day 1 on treatment period 1, followed by Treatment D (Moxifloxacin) on Day 1 of treatment period 2 followed by Treatment B (Loperamide supratherapeutic dose) on Day 1 of treatment period 3 followed by Treatment C (placebo) on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day.
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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.
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Experimenteel: Treatment Sequence 2: Treatment BACD
Participants will receive Treatment B on Day 1 of treatment period 1 followed by Treatment A on Day 1 of treatment period 2 then Treatment C on Day 1 of treatment period 3 and then Treatment D on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day.
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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.
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Experimenteel: Treatment Sequence 3: Treatment CBDA
Participants will receive Treatment C on Day 1 of treatment period 1 followed by Treatment B on Day 1 of treatment period 2 then Treatment D on Day 1 of treatment period 3 and then Treatment A on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day.
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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.
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Experimenteel: Treatment Sequence 1: Treatment DCAB
Participants will receive Treatment D on Day 1 of treatment period 1 followed by Treatment C on Day 1 of treatment period 2 then Treatment A on Day 1 of treatment period 3 and then Treatment B on Day 1 of treatment period 4. Each treatment period will be separated by a minimum of 7-day washout period and no more than 21-day.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change from Baseline in QT Interval Corrected for Heart Rate (QTc) Intervals for Loperamide
Tijdsspanne: Baseline up to 9 weeks
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Change from baseline in QTc intervals for loperamide at therapeutic and supratherapeutic doses will be reported.
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Baseline up to 9 weeks
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Percentage of Participants with Change from Baseline in T-wave Morphology
Tijdsspanne: Up to 9 weeks
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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.
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Up to 9 weeks
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Percentage of Participants with Occurrence of Abnormal U-wave Morphology
Tijdsspanne: Up to 9 weeks
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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.
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Up to 9 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Maximum Observed Plasma Concentration (Cmax) of Loperamide and its M1 Metabolite
Tijdsspanne: Up to 9 weeks
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Cmax is defined as the maximum observed plasma concentration.
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Up to 9 weeks
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Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Loperamide and its M1 Metabolite
Tijdsspanne: Up to 9 weeks
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Tmax is defined as the time to reach the maximum observed plasma concentration.
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Up to 9 weeks
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Area Under the Plasma Concentration-Time Curve from the Time of Dosing to the Last Measurable Plasma Concentration AUC (0-last) of Loperamide and its M1 Metabolite
Tijdsspanne: Up to 9 weeks
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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.
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Up to 9 weeks
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Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC[0-inifinity]) of Loperamide and M1 Metabolite
Tijdsspanne: Up to 9 weeks
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(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.
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Up to 9 weeks
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Apparent Terminal Elimination Rate Constant Lambda (z) of Loperamide and its M1 Metabolite
Tijdsspanne: Up to 9 weeks
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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.
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Up to 9 weeks
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Apparent Elimination Half-Life Associated with the Terminal Slope (t1/2) of Loperamide and M1 Metabolite
Tijdsspanne: Up to 9 weeks
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t1/2 is defined as the apparent elimination half-life associated with the terminal slope lambda (z) of the semilogarithmic drug concentration-time curve.
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Up to 9 weeks
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Metabolite to parent ratio (M/P) for (AUC[0-inifinity]) of Loperamide and M1 Metabolite
Tijdsspanne: Up to 9 weeks
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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.
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Up to 9 weeks
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Relationship Between Systemic Plasma Concentrations of Loperamide and QT/QTc Changes
Tijdsspanne: Up to 9 weeks
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The relationship between systemic plasma concentrations of loperamide and change in QT/QTc will be reported.
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Up to 9 weeks
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Number of Participants with Adverse Events (AE) as a Measure of Safety and Tolerability
Tijdsspanne: Up to 9 Weeks
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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.
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Up to 9 Weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
17 januari 2020
Primaire voltooiing (Werkelijk)
21 december 2021
Studie voltooiing (Werkelijk)
12 januari 2022
Studieregistratiedata
Eerst ingediend
9 januari 2020
Eerst ingediend dat voldeed aan de QC-criteria
9 januari 2020
Eerst geplaatst (Werkelijk)
13 januari 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
27 april 2022
Laatste update ingediend die voldeed aan QC-criteria
26 april 2022
Laatst geverifieerd
1 april 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CR108643
- 2019-003776-39 (EudraCT-nummer)
- R018553NAP1001 (Andere identificatie: Janssen Research & Development, LLC)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.
As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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