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- Klinische proef NCT03593954
A Study to Assess the Effect of Ritonavir on the Single-Dose Pharmacokinetics of JNJ-61393215 in Healthy Participants
8 november 2018 bijgewerkt door: Janssen Research & Development, LLC
An Open-Label, Fixed-Sequence Study in Healthy Subjects to Assess the Effect of Ritonavir on the Single-Dose Pharmacokinetics of JNJ-61393215
The primary purpose of this study is to assess the effect of ritonavir, on the single-dose pharmacokinetics (PK) of JNJ-61393215 in healthy participants.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
12
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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Utah
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Salt Lake City, Utah, Verenigde Staten, 84124
- PRA International
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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:
- Healthy male participants or female participants of non-childbearing potential between 18 and 55 years of age, inclusive
- Before enrollment, female participants must be of non-childbearing potential; postmenopausal state is defined as no menses for 12 months without an alternative medical cause, as documented by medical records or physician's notes and Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy
- Participants must have a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive (BMI = weight/height^2) and body weight not less than 50 kg
- Participant must be healthy based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and admission to the clinical unit. Minor abnormalities in ECG, which are not considered to be of clinical significance by the investigator, are acceptable
- Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
Exclusion Criteria:
- Participant has any clinically significant abnormal findings in physical examination, vital signs or 12-lead ECG [including QT corrected according to Fridericia's formula (QTcF) greater than (>) 450 milliseconds (msec) and less than or equal to (=<) 470 (milliseconds) msec for females, Left Bundle Branch Block, atrioventricular (AV) Block second degree or higher, permanent pacemaker or implantable cardioverter defibrillator (ICD)] at screening or admission (up to Day 1 predose), which in the opinion of the investigator are not appropriate and reasonable for the population under study
- Participant has a history of or current liver or renal insufficiency, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, any inflammatory illness or any other illness, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable
- Participant has any liver function test (including alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (ALP) and bilirubin at screening >1.5 * ULN (upper limit of normal)
- Participant has estimated glomerular filtration rate (eGFR) less than (<) 60 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) at screening (provided by the local laboratory)
- Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening
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: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: JNJ-61393215 2 mg + Ritonavir 100 mg
Participants will receive suspension of JNJ-61393215 2 mg (Day 1 and 5) orally and tablet of Ritonavir 100 mg twice a Day (Day 4-14) orally.
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Participants will receive 2 oral administrations of 2 mg JNJ-61393215 as oral suspension.
Participants will receive 100 mg of ritonavir tablet orally.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Maximum Plasma Concentration (Cmax) of JNJ-61393215
Tijdsspanne: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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Cmax is the maximum observed plasma concentration.
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Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
|
Last Quantifiable Plasma Concentration (Clast) of JNJ-61393215
Tijdsspanne: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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Clast is the last quantifiable Plasma concentration.
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Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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Time to Reach Maximum Plasma Concentration (Tmax) of JNJ-61393215
Tijdsspanne: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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Tmax is the time to reach maximum plasma concentration.
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Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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Time of the Last Quantifiable Plasma Concentration (Tlast) of JNJ-61393215
Tijdsspanne: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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Tlast is the time to last observed quantifiable plasma concentration.
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Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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Area Under Plasma-Concentration Time Curve from Time 0 to Time of Last Quantifiable Concentration (AUClast) of JNJ-61393215
Tijdsspanne: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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AUClast is the area under the plasma concentration-time curve from time zero to last quantifiable time.
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Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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Area Under Plasma-Concentration Curve from Time 0 to Infinite Time (AUCinfinity) of JNJ-61393215
Tijdsspanne: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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AUCinfinity is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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First-Order Rate Constant Associated with the Terminal Portion of the Curve [Lambda(z)] of JNJ-61393215
Tijdsspanne: Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
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Predose; Day 1 (0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hour [h]); Day 2 (24h); Day 3 (48 and 60h); Day 4 (71h 55 minutes); Day 5 (predose, 1, 2, 3, 4, 6, 8, and 16h); days 6 to 14 (Predose); Day 15 (24 h)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants with Adverse Event as a Measure of Safety and Tolerability
Tijdsspanne: Approximately 8 weeks
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An adverse event 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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Approximately 8 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)
31 juli 2018
Primaire voltooiing (Werkelijk)
19 september 2018
Studie voltooiing (Werkelijk)
19 september 2018
Studieregistratiedata
Eerst ingediend
11 juli 2018
Eerst ingediend dat voldeed aan de QC-criteria
11 juli 2018
Eerst geplaatst (Werkelijk)
20 juli 2018
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 november 2018
Laatste update ingediend die voldeed aan QC-criteria
8 november 2018
Laatst geverifieerd
1 november 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CR108479
- 61393215EDI1003 (Andere identificatie: Janssen Research & Development, LLC)
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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