PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants
7. mars 2017 oppdatert av: Biogen
A Phase 1 Pharmacokinetics and Safety Study of BIIB074 in Healthy Japanese and Caucasian Subjects
The primary objectives of this study are: To evaluate pharmacokinetics (PK) properties of BIIB074 administered as a single oral dose in healthy Japanese and Caucasian participants; and To evaluate the PK properties of BIIB074 administered as repeated oral doses in healthy Japanese participants.
The secondary objective of this study is to assess the safety and tolerability of BIIB074 administered as a single oral dose (Japanese and Caucasian participants) and as repeated oral doses (Japanese participants).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
64
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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Leeds, Storbritannia, LS2 9LH
- Research Site
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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
18 år til 55 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Key Inclusion Criteria:
- Japanese or Caucasian.
- Japanese participants must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
- Must have a body mass index between 18 and 30 kg/m2, inclusive.
Key Exclusion Criteria:
- Previous exposure to BIIB074, with the exception that Japanese participants who complete Part 1.
- Use of any oral, injected, or implanted hormonal method of contraception that contains ethinyl estradiol within 28 days of Day -1 and an unwillingness to refrain from product use during study participation.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Part 1
48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio
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Administreres som spesifisert i behandlingsarmen
Andre navn:
Matchet placebo
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Eksperimentell: Part 2
16 participants: Multiple Ascending Dosing of BIIB074 or placebo in a 6:2 ratio; 3 times daily [TID] in cohort 4 for 6 days and one time (QD) for 1 day and 2 times daily [BID] in cohort 5 for 6 days and QD for 1 day
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Administreres som spesifisert i behandlingsarmen
Andre navn:
Matchet placebo
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )
Tidsramme: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
|
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Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)
Tidsramme: 15 minutes prior to dosing up to 96 hours post dose
|
15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)
Tidsramme: 15 minutes prior to dosing up to 96 hours post dose
|
15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 to time of the last measurable drug concentration (AUC0-t)
Tidsramme: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)
Tidsramme: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
|
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Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)
Tidsramme: 15 minutes prior to dosing up to 96 hours post dose
|
15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)
Tidsramme: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
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Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)
Tidsramme: 15 minutes prior to dosing up to 96 hours post dose
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15 minutes prior to dosing up to 96 hours post dose
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Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax
Tidsramme: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by tmax
Tidsramme: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by area under the concentration time curve within a dosing interval (AUCtau)
Tidsramme: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by trough concentration after repeated doses (Ctrough)
Tidsramme: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by t1/2
Tidsramme: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
|
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Part 2: PK of BIIB074 repeated oral dose as assessed by apparent volume of distribution at steady state (Vss/F)
Tidsramme: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Part 2: PK of BIIB074 repeated oral dose as assessed by apparent clearance at steady state (CLss/F)
Tidsramme: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
|
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Part 2: PK of BIIB074 repeated oral dose as assessed by accumulation ratio (Rac)
Tidsramme: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
|
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Part 2: PK of BIIB074 repeated oral dose as assessed by MRAUC
Tidsramme: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsramme: Up to 2 weeks post Part 2 of the Treatment Period
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Up to 2 weeks post Part 2 of the Treatment Period
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Number of participants with clinically significant laboratory assessment abnormalities
Tidsramme: Up to 2 weeks post Part 2 of the Treatment Period
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Up to 2 weeks post Part 2 of the Treatment Period
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Number of participants with clinically significant vital sign abnormalities
Tidsramme: Up to 2 weeks post Part 2 of the Treatment Period
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Up to 2 weeks post Part 2 of the Treatment Period
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Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Tidsramme: Up to 2 weeks post Part 2 of the Treatment Period
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Up to 2 weeks post Part 2 of the Treatment Period
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Number of participants with clinically significant physical examinations abnormalities
Tidsramme: Up to 2 weeks post Part 2 of the Treatment Period
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Up to 2 weeks post Part 2 of the Treatment Period
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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
1. august 2016
Primær fullføring (Faktiske)
1. februar 2017
Studiet fullført (Faktiske)
1. februar 2017
Datoer for studieregistrering
Først innsendt
11. juli 2016
Først innsendt som oppfylte QC-kriteriene
11. juli 2016
Først lagt ut (Anslag)
13. juli 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. mars 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mars 2017
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 802HV106
- 2016-000874-39 (EudraCT-nummer)
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