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PK and Safety Study of BIIB074 in Healthy Japanese and Caucasian Participants

7 mars 2017 uppdaterad 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

64

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 55 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Part 1
48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio
Läkemedel: BIIB074
Administreras enligt beskrivningen i behandlingsarmen
Andra namn:
  • CNV1014802
Läkemedel: Placebo
Matchad placebo
Experimentell: 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
Läkemedel: BIIB074
Administreras enligt beskrivningen i behandlingsarmen
Andra namn:
  • CNV1014802
Läkemedel: Placebo
Matchad placebo

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )
Tidsram: 15 minutes prior to dosing up to 96 hours post dose
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)
Tidsram: 15 minutes prior to dosing up to 96 hours post dose
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)
Tidsram: 15 minutes prior to dosing up to 96 hours post dose
15 minutes prior to dosing up to 96 hours post dose
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)
Tidsram: 15 minutes prior to dosing up to 96 hours post dose
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)
Tidsram: 15 minutes prior to dosing up to 96 hours post dose
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)
Tidsram: 15 minutes prior to dosing up to 96 hours post dose
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)
Tidsram: 15 minutes prior to dosing up to 96 hours post dose
15 minutes prior to dosing up to 96 hours post dose
Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)
Tidsram: 15 minutes prior to dosing up to 96 hours post dose
15 minutes prior to dosing up to 96 hours post dose
Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax
Tidsram: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by tmax
Tidsram: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by area under the concentration time curve within a dosing interval (AUCtau)
Tidsram: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by trough concentration after repeated doses (Ctrough)
Tidsram: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by t1/2
Tidsram: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by apparent volume of distribution at steady state (Vss/F)
Tidsram: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by apparent clearance at steady state (CLss/F)
Tidsram: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by accumulation ratio (Rac)
Tidsram: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
Part 2: PK of BIIB074 repeated oral dose as assessed by MRAUC
Tidsram: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7
15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

Sekundära resultatmått

Resultatmått
Tidsram
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tidsram: Up to 2 weeks post Part 2 of the Treatment Period
Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant laboratory assessment abnormalities
Tidsram: Up to 2 weeks post Part 2 of the Treatment Period
Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant vital sign abnormalities
Tidsram: Up to 2 weeks post Part 2 of the Treatment Period
Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Tidsram: Up to 2 weeks post Part 2 of the Treatment Period
Up to 2 weeks post Part 2 of the Treatment Period
Number of participants with clinically significant physical examinations abnormalities
Tidsram: Up to 2 weeks post Part 2 of the Treatment Period
Up to 2 weeks post Part 2 of the Treatment Period

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Biogen

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2016

Primärt slutförande (Faktisk)

1 februari 2017

Avslutad studie (Faktisk)

1 februari 2017

Studieregistreringsdatum

Först inskickad

11 juli 2016

Först inskickad som uppfyllde QC-kriterierna

11 juli 2016

Första postat (Uppskatta)

13 juli 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 mars 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 mars 2017

Senast verifierad

1 mars 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 802HV106
  • 2016-000874-39 (EudraCT-nummer)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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