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A Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Participants (Part I), and After Multiple Dose Regimens in Participants With Chronic Hepatitis B (Part II)

2. Juli 2019 aktualisiert von: Janssen Sciences Ireland UC

A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-human Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Subjects (Part I), and After Multiple Dose Regimens in Subjects With Chronic Hepatitis B (Part II)

The purpose of this study is to evaluate pharmacokinetics and safety data including serious and other adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory results (including biochemistry, hematology, and urine).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Part 1: This is a first-in-human (FIH), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study medication assigned to participants by chance), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study. Part 1 includes healthy adult participants, divided into 3 panels (Panel 1, 2 and 3) and in Part 2 adult Chronic Hepatitis B Participants will be included, in Sessions VIII to XI and Optional Sessions A-B-C (Panel 4). The study will consists of screening phase (part 1: [less than or equal to <=28 days before the first intake of study drug; part 2: [<=56 to greater than or equal to {>=} 20 days before the first intake of study drug), Treatment Phase (multiple dose phase in part 1: Day -1 up to 12 or 19 days; part 2: up to 4 weeks) and Follow up Phase (part 1: 30-35 days after last study drug intake or after dropout; part 2: up to week 8 after actual end of study drug treatment). Participants' safety will be evaluated throughout the study.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

87

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Belgien
      • Brussel, Belgien
      • Edegem, Belgien
      • Mechelen, Belgien
      • Merksem, Belgien
  • Bulgarien
      • Sofia, Bulgarien
  • Deutschland
      • Essen, Deutschland
      • Hannover, Deutschland
      • Wiesbaden, Deutschland
  • Frankreich
      • Clichy, Frankreich
      • La Tronche, Frankreich
      • Lyon, Frankreich
      • Paris, Frankreich
  • Georgia
      • Tbilisi, Georgia
  • Malaysia
      • Kuala Lumpur, Malaysia
  • Moldawien, Republik
      • Chisinau, Moldawien, Republik
  • Rumänien
      • Bucuresti, Rumänien
      • Timisoara, Rumänien
  • Spanien
      • Barcelona, Spanien
      • Madrid, Spanien
      • Santander, Spanien
      • Sevilla, Spanien
      • Valencia, Spanien
  • Taiwan
      • Kaohsiung, Taiwan
      • Keelung, Taiwan
      • Taichung, Taiwan
      • Taipei City, Taiwan
      • Taoyuan, Taiwan

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • For Part II, a female participant must be either of a) Non-childbearing potential defined as: 1) Postmenopausal: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level (greater than (>)40 international unit per milliliter (IU/L) or milli-international units per milliliter (mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy, however in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient, or 2) Permanently sterile: Permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy, or b) Childbearing potential and practicing sexual abstinence or a highly effective method of contraception from screening onwards and agree to continue to use the same method of contraception throughout study treatment and for at least 90 days after the last dose of study drug (or longer, if dictated by local regulation)
  • Female participants should have a negative serum pregnancy test at screening
  • Healthy Participants: Participants must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m2), extremes included
  • Chronic Hepatitis B Participants: Participants must have lack of advanced liver disease, ie, either: Metavir F0-F2 (or comparable histologic scoring system) as determined on a liver biopsy within one year of the screening visit; a result based on specific radiologic liver disease staging modalities (eg, Fibroscan, AFRI, magnetic resonance imaging [MRI]-Elastography) compatible with Metavir F0-F2 within 6 months of the screening visit
  • Chronic Hepatitis B Participants: Participants must have HBV DNA of greater than or equal [>=] 2,000 international unit per milliliter (IU/mL) at screening
  • Chronic Hepatitis B Participants: Participants must be aged between 18 years to 65 years, have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 35.0 kilogram per square meter (kg/m^2), extremes included

Exclusion Criteria:

  • Healthy Participants: Participants with a past history of cardiac arrhythmias (example, extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
  • Healthy Participants: Female participants who are breastfeeding at screening
  • Healthy Participants: Participants with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at screening
  • Chronic Hepatitis B Participants: Participants with current HCV infection (confirmed by HCV antibody or HCV RNA) or hepatitis delta virus (HDV) infection (confirmed by HDV antibody) at screening
  • Chronic Hepatitis B Participants: Participants with positivity of anti-HBs antibodies
  • Chronic Hepatitis B Participants: Participants with a past history of cardiac arrhythmias (eg, extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
  • Chronic Hepatitis B Participants: Female participants who are breastfeeding at screening

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Part 1: Single Dose Escalation
The single dose escalation phase of the study will consist of 6 dosing sessions (Sessions I to VI) evaluated in 2 panels (Panels 1 and 2). The dose of JNJ-56136379 will be consecutively escalated over 5 levels, alternating between the 2 panels. Panel 1 will receive 3 single doses (SD1, SD3 and SD3fed) in Sessions I, III and V, respectively. Panel 2 will receive 3 single doses (SD2, SD4 and SD5) in Sessions II, IV and VI, respectively. There will be a washout period of at least 14 days between consecutive JNJ-56136379/placebo dosing in each individual participant.
Arzneimittel: JNJ-56136379
JNJ-56136379 oral tablets will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
Arzneimittel: Placebo
Matching placebo to JNJ-56136379 will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
Experimental: Part 1: Multiple dose session
After completion of the fifth single dose session another panel of healthy participant (panel 3) receive multiple doses of JNJ-56136379 at one dose level (MDx) or placebo for 12 or 19 consecutive days (Session VII) in fed or fasted conditions.
Arzneimittel: JNJ-56136379
JNJ-56136379 oral tablets will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
Arzneimittel: Placebo
Matching placebo to JNJ-56136379 will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
Experimental: Part 2: Multiple dose escalation
Multiple dose levels will be given in Panel 4 in Session VIII (European sites), Sessions IX and X (European and/or Asian sites) Session XI (Asian sites) for 28 consecutive days in fed conditions. Optional Sessions A-B-C (Panel 4) used for further dose evaluations at European and/or Asian sites. Per session, participants will receive JNJ 56136379 or placebo. Dose progression to the next multiple dose level may be adapted based on the emerging safety and PK outcome of the previous dosing levels.
Arzneimittel: JNJ-56136379
JNJ-56136379 oral tablets will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
Arzneimittel: Placebo
Matching placebo to JNJ-56136379 will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Zeitfenster: Until the last study-related activity (30-35 days after last dosing)
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Until the last study-related activity (30-35 days after last dosing)
Part 2: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
Zeitfenster: Up to Week 12
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Up to Week 12
Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Abnormal Physical Examinations
Zeitfenster: 30-35 days after last study drug intake or after dropout
Physical examinations (including body weight measurement and skin examination) will be performed.
30-35 days after last study drug intake or after dropout
Part 2: Number of Participants With Abnormal Physical Examinations
Zeitfenster: Up to Week 8
Physical examinations (including body weight measurement and skin examination) will be performed.
Up to Week 8
Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Abnormal Vital Signs
Zeitfenster: 30-35 days after last study drug intake or after dropout
Vital signs (Supine Blood Pressure [SBP], Diastolic Blood Pressure [DBP] pulse rate: supine and standing) will be performed.
30-35 days after last study drug intake or after dropout
Part 2: Number of Participants With Abnormal Vital Signs
Zeitfenster: Up to Week 8
Vital signs (SBP, DBP pulse rate: supine and standing) will be performed.
Up to Week 8
Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Clinically Significant Laboratory Findings
Zeitfenster: 30-35 days after last study drug intake or after dropout
The laboratory abnormalities will be determined according to the criteria specified in the World Health Organization (WHO) Toxicity Grading Scale and in accordance with the normal ranges of the clinical laboratory.
30-35 days after last study drug intake or after dropout
Part 2: Number of Participants With Clinically Significant Laboratory Findings
Zeitfenster: Up to Week 8
The laboratory abnormalities will be determined according to the criteria specified in the World Health Organization (WHO) Toxicity Grading Scale and in accordance with the normal ranges of the clinical laboratory.
Up to Week 8
Part 1: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration
Zeitfenster: Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
Cmax is the Maximum observed plasma concentration.
Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
Part 1: Maximum Observed Plasma Concentration (Cmax) After Multiple Dose Administration
Zeitfenster: Pre-dose, 0.5 hr, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr Day 1; post-dose on Day 12
Cmax is the Maximum observed plasma concentration.
Pre-dose, 0.5 hr, 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr Day 1; post-dose on Day 12
Part 2: Maximum Observed Plasma Concentration (Cmax)
Zeitfenster: Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28
Cmax is the Maximum observed plasma concentration.
Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28
Part 1: Area Under the Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast) After Single Dose Administration
Zeitfenster: Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
AUClast is the area under the curve from time 0 to the time of the last measurable Concentration.
Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
Part 2: Area Under the Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
Zeitfenster: Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28
AUClast is the area under the curve from time 0 to the time of the last measurable Concentration.
Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28
Part 1: Area Under the Curve From Time 0 to Infinity (AUC infinity) After Single Dose Administration
Zeitfenster: Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
AUC infinity is the area under the curve from time 0 to infinity.
Pre-dose, 0.5 hour (hr), 1, 1.5, 2, 3, 4, 6, 8, 12 and 16 hr post-dose on Day 1
Part 2: Area Under the Curve From Time 0 to Infinity (AUC infinity)
Zeitfenster: Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28
AUC infinity is the area under the curve from time 0 to infinity.
Pre-dose, 8, 12 hr post-dose on Day 1; post-dose on Day 28

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Part 2: Change From Baseline in Mean Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA)
Zeitfenster: Up to week 12
HBV DNA will be quantified using an in vitro nucleic acid amplification test for the quantification of HBV DNA.
Up to week 12
Part 2: Maximum Decrease in HBV DNA (Baseline-subtracted Mean)
Zeitfenster: Up to week 12
HBV DNA will be quantified using an in vitro nucleic acid amplification test for the quantification of HBV DNA.
Up to week 12
Part 2: Changes in Hepatitis B Surface Antigen (HBsAg) Levels
Zeitfenster: Up to week 12
Quantitative HBsAg and levels will be determined from samples using standard serologic assays.
Up to week 12
Part II: Percentage of Participants with Treatment Emerging Mutations
Zeitfenster: Up to week 12
Treatment induced emerging mutations will be assessed by comparing the HBV genome sequence obtained at baseline with sequences obtained post-baseline.
Up to week 12
Part II: Change From Baseline in HBV DNA (Antiviral Activity) in Chronic Hepatitis B (CHB) Participants with Sequence Variations in the HBV Genome
Zeitfenster: Up to week 12
Sequence variations in the HBV genome will be assessed by sequencing of the viral genome. Antiviral activity will be assessed by measuring change from baseline in HBV DNA concentration using in vitro nucleic acid amplification test for the quantification of HBV DNA and compared between participants with and without HBV sequence variations.
Up to week 12

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Janssen Sciences Ireland UC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. Dezember 2015

Primärer Abschluss (Tatsächlich)

29. Juni 2018

Studienabschluss (Tatsächlich)

29. Juni 2018

Studienanmeldedaten

Zuerst eingereicht

2. Dezember 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Januar 2016

Zuerst gepostet (Schätzen)

25. Januar 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juli 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. Juli 2019

Zuletzt verifiziert

1. Juli 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CR108092
  • 56136379HPB1001 (Andere Kennung: Janssen Sciences Ireland UC)
  • 2015-003724-30 (EudraCT-Nummer)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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