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Completed

NCT Number: NCT02831517

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

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).

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Key information

Conditions

Healthy Cranial Nerve Diseases Facial Nerve Diseases Facial Neuralgia Mouth Diseases Nervous System Diseases Stomatognathic Diseases Trigeminal Nerve Diseases Trigeminal Neuralgia

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIIB074

Drug

Administered as specified in the treatment arm

Other names: CNV1014802

Placebo

Drug

Matched Placebo

Primary outcomes

  1. Part 1: PK of BIIB074 single oral dose as assessed by maximum observed concentration (Cmax )

    Time frame: 15 minutes prior to dosing up to 96 hours post dose

  2. Part 1: PK of BIIB074 single oral dose as assessed by time to reach Cmax (tmax)

    Time frame: 15 minutes prior to dosing up to 96 hours post dose

  3. Part 1: PK of BIIB074 single oral dose as assessed by area under the concentration time curve from time 0 extrapolated to infinity (AUCinf)

    Time frame: 15 minutes prior to dosing up to 96 hours post dose

  4. 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)

    Time frame: 15 minutes prior to dosing up to 96 hours post dose

  5. Part 1: PK of BIIB074 single oral dose as assessed by terminal elimination half-life (t1/2)

    Time frame: 15 minutes prior to dosing up to 96 hours post dose

  6. Part 1: PK of BIIB074 single oral dose as assessed by apparent volume of distribution (Vd/F)

    Time frame: 15 minutes prior to dosing up to 96 hours post dose

  7. Part 1: PK of BIIB074 single oral dose as assessed by apparent total body clearance (CL/F)

    Time frame: 15 minutes prior to dosing up to 96 hours post dose

  8. Part 1: PK of BIIB074 single oral dose as assessed by metabolite to parent ratio in AUC (MRAUC)

    Time frame: 15 minutes prior to dosing up to 96 hours post dose

  9. Part 2: PK of BIIB074 repeated oral dose as assessed by Cmax

    Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

  10. Part 2: PK of BIIB074 repeated oral dose as assessed by tmax

    Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

  11. Part 2: PK of BIIB074 repeated oral dose as assessed by area under the concentration time curve within a dosing interval (AUCtau)

    Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

  12. Part 2: PK of BIIB074 repeated oral dose as assessed by trough concentration after repeated doses (Ctrough)

    Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

  13. Part 2: PK of BIIB074 repeated oral dose as assessed by t1/2

    Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

  14. Part 2: PK of BIIB074 repeated oral dose as assessed by apparent volume of distribution at steady state (Vss/F)

    Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

  15. Part 2: PK of BIIB074 repeated oral dose as assessed by apparent clearance at steady state (CLss/F)

    Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

  16. Part 2: PK of BIIB074 repeated oral dose as assessed by accumulation ratio (Rac)

    Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

  17. Part 2: PK of BIIB074 repeated oral dose as assessed by MRAUC

    Time frame: 15 minutes prior to dosing on Day 1 up to 96 hours post dose on Day 7

Secondary outcomes

  1. Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 2 weeks post Part 2 of the Treatment Period

  2. Number of participants with clinically significant laboratory assessment abnormalities

    Time frame: Up to 2 weeks post Part 2 of the Treatment Period

  3. Number of participants with clinically significant vital sign abnormalities

    Time frame: Up to 2 weeks post Part 2 of the Treatment Period

  4. Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities

    Time frame: Up to 2 weeks post Part 2 of the Treatment Period

  5. Number of participants with clinically significant physical examinations abnormalities

    Time frame: Up to 2 weeks post Part 2 of the Treatment Period

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Phase 1 Pharmacokinetics and Safety Study of BIIB074 in Healthy Japanese and Caucasian Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 13, 2016
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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