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Completed

NCT Number: NCT05148481

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Treatment and study plan

BIIB104

Drug

Administered as specified in the treatment arm

Placebo

Drug

Administered as specified in the treatment arm

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of BIIB104

    Time frame: Up to Day 11

  2. Time to Reach Maximum Observed Concentration (Tmax) of BIIB104

    Time frame: Up to Day 11

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

    Time frame: Up to Day 11

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

    Time frame: Up to Day 11

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

    Time frame: Up to Day 11

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

    Time frame: Up to Day 11

  7. Apparent Total Body Clearance (CL/F) of BIIB104

    Time frame: Up to Day 11

  8. Apparent Volume of Distribution (Vz/F) of BIIB104

    Time frame: Up to Day 11

  9. Elimination Half-Life (t½) of BIIB104

    Time frame: Up to Day 11

  10. Accumulation Ratio for Steady State of BIIB104

    Time frame: Up to Day 11

    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)].

  11. Trough Concentration (Ctrough) of BIIB104

    Time frame: Up to Day 11

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Day 1 up to Day 25

    An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.

  2. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: From screening up to Day 25

    A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 8, 2021
Registry last updated
Apr 18, 2023

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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