- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02821858
Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants
28. mars 2018 oppdatert av: 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).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Surrey, Storbritannia
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
20 år til 55 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Panel 1: Treatment A
Participants will receive odalasvir (ODV) 50 milligram (mg) (n=8) or placebo (n=2) on Day 1.
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Matchende placebo vil bli administrert.
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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Eksperimentell: Panel 1: Treatment B
Participants will receive ODV 100 mg (n=8) or placebo (n=2) on Day 1.
|
Matchende placebo vil bli administrert.
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.
|
|
Eksperimentell: Panel 1: Treatment C
Participants will receive ODV 300 mg (n=8) or placebo (n=2) on Day 1.
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Matchende placebo vil bli administrert.
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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Eksperimentell: 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 bli administrert.
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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Eksperimentell: 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.
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Matchende placebo vil bli administrert.
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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Eksperimentell: 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.
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Matchende placebo vil bli administrert.
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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Maximum Observed Concentration (Cmax) of Odalasvir (ODV)
Tidsramme: From Day 1 to Day 14 after intake of ODV
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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
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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
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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
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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
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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 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
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Up to 50-55 days after intake of ODV
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Maximum Observed Concentration (Cmax) of AL-335
Tidsramme: From Day 1 to Day 4 after intake of AL-335
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The Cmax is the maximum observed analyte concentration.
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From Day 1 to Day 4 after intake of AL-335
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Time to Reach Maximum Observed Concentration (Tmax) of AL-335
Tidsramme: From Day 1 to Day 4 after intake of AL-335
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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
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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
|
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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
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Up to 30 to 35 days after last intake of AL-335
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Janssen Research and Developement, LLC Clinical Trial, Janssen Research and Developement, LLC
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. juni 2016
Primær fullføring (Faktiske)
9. september 2016
Studiet fullført (Faktiske)
30. september 2016
Datoer for studieregistrering
Først innsendt
10. juni 2016
Først innsendt som oppfylte QC-kriteriene
29. juni 2016
Først lagt ut (Anslag)
4. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mars 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. mars 2018
Sist bekreftet
1. mars 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CR108178
- 64294178HPC1005 (Annen identifikator: Janssen Research & Development, LLC)
- 2015-005639-42 (EudraCT-nummer)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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