A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants

NCT05148481 | Completed Phase 1 FDA Drug

• 1 other identifier: 263HV108
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective of the study is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered twice daily (BID) for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (11)

• Maximum Observed Concentration (Cmax) of BIIB104

  Up to Day 11

• Time to Reach Maximum Observed Concentration (Tmax) of BIIB104

  Up to Day 11

• Area Under the Concentration-Time Curve Within a Dosing Interval for Single Dose [AUC(tau,sd)] of BIIB104

  Up to Day 11

• Maximum Observed Concentration at Steady State (Cmax,ss) of BIIB104

  Up to Day 11

• Time to Reach Maximum Observed Concentration at Steady State (Tmax,ss) of BIIB104

  Up to Day 11

• Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State [AUC(tau,ss)] of BIIB104

  Up to Day 11

• Apparent Total Body Clearance (CL/F) of BIIB104

  Up to Day 11

• Apparent Volume of Distribution (Vz/F) of BIIB104

  Up to Day 11

• Elimination Half-Life (t½) of BIIB104

  Up to Day 11

• Accumulation Ratio for Steady State of BIIB104

  Accumulation ratio for steady state is defined as area under the concentration-time curve over a uniform dosing interval tau at steady state divided by area under the concentration-time curve within a dosing interval for single dose \[AUC(tau,ss)/AUC(tau,sd)\].

  Up to Day 11

• Trough Concentration (Ctrough) of BIIB104

  Up to Day 11

Secondary Outcomes (2)

• Number of Participants with Adverse Events (AEs)

  Day 1 up to Day 25

• Number of Participants with Serious Adverse Events (SAEs)

  From screening up to Day 25

Study Arms (3)

BIIB104: Dose 1

EXPERIMENTAL

Japanese and non-Japanese participants will receive BIIB104, Dose 1, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10.

Drug: BIIB104

BIIB104: Dose 2

EXPERIMENTAL

Japanese and non-Japanese participants will receive BIIB104, Dose 2, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10.

Drug: BIIB104

Placebo

PLACEBO COMPARATOR

Japanese and non-Japanese participants will receive BIIB104-matching placebo, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10.

Drug: Placebo

Interventions

BIIB104 DRUG

Administered as specified in the treatment arm

BIIB104: Dose 1; BIIB104: Dose 2

Placebo DRUG

Administered as specified in the treatment arm

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a body mass index between 18 and 30 kilograms per meter square (kg/m\^2), inclusive, and total body weight \>50 kilograms (kg) \[110 pounds (lb)\].
• For Japanese participants, was born in Japan, and biological parents and grandparents were of Japanese origin.
• For Japanese participants, if living outside Japan for more than 5 years, must not have significantly modified diet since leaving Japan.
• Non-Japanese participants must have a screening weight within ±20% of the mean value for Japanese participants.

You may not qualify if:

• Participation in other studies involving treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to randomization and/or during study participation.
• History of severe allergic or anaphylactic reactions, systemic hypersensitivity reaction to BIIB104, or any allergic reactions that in the opinion of the investigator are likely to be exacerbated by any component of the study treatment.
• History of seizures or a condition with risk of seizures.
• History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
• Chronic, recurrent, or serious infection, as determined by the investigator, within 6 months prior to screening or between screening and Day 1.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Anaheim, California, 92801, United States

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 8, 2021
• Study Start: November 23, 2021
• Primary Completion: January 30, 2022
• Study Completion: February 12, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)