- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02821858
Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants
28. marts 2018 opdateret af: Janssen Research & Development, LLC
A Phase 1, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Subjects
The purpose of this study is to investigate the pharmacokinetics (PK), safety and tolerability following single oral administration of ascending doses of odalasvir (ODV) in healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability following single oral administration of ascending doses of AL-335 in healthy Japanese participants (Panel 2; Sequential Design).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Surrey, Det Forenede Kongerige
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 55 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Participant must be a Japanese participant who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
- Participant must have a body mass index (BMI: weight in kilogram [kg] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square (kg/m^2), extremes included and a body weight not less than 50.0 kilogram (kg)
- Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at Screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
- Participant must have a blood pressure (after the participant supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
- Female participant must agree to not donate eggs (ova, oocytes) for the purpose of assisted reproduction during the study and for a period of 60 days (Panel 1) or 30 days (Panel 2) after study drug administration or until the last follow-up visit, whichever occurs later
Exclusion Criteria:
- Participant has a history of liver or renal insufficiency (estimated creatinine clearance below 80 milliliters per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic or metabolic disturbances
- Participant has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
- Participant with a past history of heart arrhythmias (for example, extra systolic beats or tachycardia at rest); risk factors associated with Torsade de Pointes such as hypokalemia or family history of short/long QT syndrome or sudden unexplained death (including sudden infant death syndrome) in a first-degree relative [for example, sibling, offspring, or biological parent])
- Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
- Participant has known allergies, hypersensitivity, or intolerance to odalasvir (ODV) or AL-335 or its excipients
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Panel 1: Treatment A
Participants will receive odalasvir (ODV) 50 milligram (mg) (n=8) or placebo (n=2) on Day 1.
|
Matchende placebo vil blive givet.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
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|
Eksperimentel: Panel 1: Treatment B
Participants will receive ODV 100 mg (n=8) or placebo (n=2) on Day 1.
|
Matchende placebo vil blive givet.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
|
|
Eksperimentel: Panel 1: Treatment C
Participants will receive ODV 300 mg (n=8) or placebo (n=2) on Day 1.
|
Matchende placebo vil blive givet.
ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
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|
Eksperimentel: Panel 2: Treatment D
Participants will receive AL-335 400 mg (n=8) or placebo (n=2) on Day 1 of Period 1.
Each treatment period will be separated by a washout period of 7 days.
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Matchende placebo vil blive givet.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
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Eksperimentel: Panel 2: Treatment E
Participants will receive AL-335 800 mg (n=8) or placebo (n=2) on Day 1 of Period 2. Each treatment period will be separated by a washout period of 7 days.
|
Matchende placebo vil blive givet.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
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|
Eksperimentel: Panel 2: Treatment F
Participants will receive AL-335 1,200 mg (n=8) or placebo (n=2) on Day 1 of Period 3.
Each treatment period will be separated by a washout period of 7 days.
|
Matchende placebo vil blive givet.
AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Observed Concentration (Cmax) of Odalasvir (ODV)
Tidsramme: From Day 1 to Day 14 after intake of ODV
|
The Cmax is the maximum observed analyte concentration.
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From Day 1 to Day 14 after intake of ODV
|
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Time to Reach Maximum Observed Concentration (Tmax) of ODV
Tidsramme: From Day 1 to Day 14 after intake of ODV
|
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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From Day 1 to Day 14 after intake of ODV
|
|
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of ODV
Tidsramme: From Day 1 to Day 50-55 after intake of ODV
|
The (AUC [0-last]) is the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
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From Day 1 to Day 50-55 after intake of ODV
|
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Elimination Rate Constant (Lambda[z]) of ODV
Tidsramme: From Day 1 to Day 50-55 after intake of ODV
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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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From Day 1 to Day 50-55 after intake of ODV
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Elimination Half-Life (t1/2) of ODV
Tidsramme: From Day 1 to Day 50-55 after intake of ODV
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Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
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From Day 1 to Day 50-55 after intake of ODV
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Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of ODV
Tidsramme: From Day 1 to Day 50-55 after intake of ODV
|
The AUC (0-infinity) 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.
|
From Day 1 to Day 50-55 after intake of ODV
|
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Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for ODV
Tidsramme: Up to 50-55 days after intake of ODV
|
Up to 50-55 days after intake of ODV
|
|
|
Maximum Observed Concentration (Cmax) of AL-335
Tidsramme: From Day 1 to Day 4 after intake of AL-335
|
The Cmax is the maximum observed analyte concentration.
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From Day 1 to Day 4 after intake of AL-335
|
|
Time to Reach Maximum Observed Concentration (Tmax) of AL-335
Tidsramme: From Day 1 to Day 4 after intake of AL-335
|
The Tmax is defined as actual sampling time to reach maximum observed concentration.
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From Day 1 to Day 4 after intake of AL-335
|
|
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUClast) of AL-335
Tidsramme: From Day 1 to Day 4 after intake of AL-335
|
The (AUC [0-last]) is the area under the concentration-time curve from time 0 to time of the last quantifiable concentration.
|
From Day 1 to Day 4 after intake of AL-335
|
|
Elimination Rate Constant (Lambda[z]) of AL-335
Tidsramme: From Day 1 to Day 4 after intake of AL-335
|
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.
|
From Day 1 to Day 4 after intake of AL-335
|
|
Elimination Half-Life (t1/2) of AL-335
Tidsramme: From Day 1 to Day 4 after intake of AL-335
|
Elimination half-life (t[1/2]) is associated with the terminal slope (lambda [z]) of the semi-logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
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From Day 1 to Day 4 after intake of AL-335
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|
Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of AL-335
Tidsramme: From Day 1 to Day 4 after intake of AL-335
|
The AUC (0-infinity) 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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From Day 1 to Day 4 after intake of AL-335
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Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability for AL-335
Tidsramme: Up to 30 to 35 days after last intake of AL-335
|
Up to 30 to 35 days after last intake of AL-335
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Janssen Research and Developement, LLC Clinical Trial, Janssen Research and Developement, LLC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. juni 2016
Primær færdiggørelse (Faktiske)
9. september 2016
Studieafslutning (Faktiske)
30. september 2016
Datoer for studieregistrering
Først indsendt
10. juni 2016
Først indsendt, der opfyldte QC-kriterier
29. juni 2016
Først opslået (Skøn)
4. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. marts 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. marts 2018
Sidst verificeret
1. marts 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR108178
- 64294178HPC1005 (Anden identifikator: Janssen Research & Development, LLC)
- 2015-005639-42 (EudraCT nummer)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
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