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

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ClinicalTrials.gov Identifier: NCT02831517
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Healthy Trigeminal Neuralgia Drug: BIIB074 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Pharmacokinetics and Safety Study of BIIB074 in Healthy Japanese and Caucasian Subjects
Study Start Date : August 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1
48 participants: Cohorts 1,2 and 3 (Single Ascending Dose of BIIB074 or placebo) in a 6:2 ratio
Drug: BIIB074
Administered as specified in the treatment arm
Other Name: CNV1014802

Drug: Placebo
Matched Placebo

Experimental: 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
Drug: BIIB074
Administered as specified in the treatment arm
Other Name: CNV1014802

Drug: Placebo
Matched Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831517


Locations
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United Kingdom
Research Site
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02831517     History of Changes
Other Study ID Numbers: 802HV106
2016-000874-39 ( EudraCT Number )
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Trigeminal Neuralgia
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases