PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants
7. marts 2017 opdateret af: 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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
64
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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Leeds, Det Forenede Kongerige, LS2 9LH
- Research Site
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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
18 år til 55 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
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: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Indgives som specificeret i behandlingsarmen
Andre navne:
Matchet placebo
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Eksperimentel: 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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Indgives som specificeret i behandlingsarmen
Andre navne:
Matchet placebo
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
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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 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
1. august 2016
Primær færdiggørelse (Faktiske)
1. februar 2017
Studieafslutning (Faktiske)
1. februar 2017
Datoer for studieregistrering
Først indsendt
11. juli 2016
Først indsendt, der opfyldte QC-kriterier
11. juli 2016
Først opslået (Skøn)
13. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. marts 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. marts 2017
Sidst verificeret
1. marts 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 802HV106
- 2016-000874-39 (EudraCT nummer)
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