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

Healthy Volunteer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05148481
• Other study ID #: 263HV108
• Status: Completed
• Phase: Phase 1
• Start date: November 23, 2021
• Est. completion date: February 12, 2022

Study information

• Verified date: April 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 12, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• BIIB104
Administered as specified in the treatment arm
• Placebo
Administered as specified in the treatment arm

Locations

Country	Name	City	State
United States	Research Site	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentration (Cmax) of BIIB104		Up to Day 11
Primary	Time to Reach Maximum Observed Concentration (Tmax) of BIIB104		Up to Day 11
Primary	Area Under the Concentration-Time Curve Within a Dosing Interval for Single Dose [AUC(tau,sd)] of BIIB104		Up to Day 11
Primary	Maximum Observed Concentration at Steady State (Cmax,ss) of BIIB104		Up to Day 11
Primary	Time to Reach Maximum Observed Concentration at Steady State (Tmax,ss) of BIIB104		Up to Day 11
Primary	Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State [AUC(tau,ss)] of BIIB104		Up to Day 11
Primary	Apparent Total Body Clearance (CL/F) of BIIB104		Up to Day 11
Primary	Apparent Volume of Distribution (Vz/F) of BIIB104		Up to Day 11
Primary	Elimination Half-Life (t½) of BIIB104		Up to Day 11
Primary	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
Primary	Trough Concentration (Ctrough) of BIIB104		Up to Day 11
Secondary	Number of Participants with Adverse Events (AEs)	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.	Day 1 up to Day 25
Secondary	Number of Participants with Serious Adverse Events (SAEs)	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.	From screening up to Day 25