Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants

Healthy Volunteers 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: NCT04079101
• Other study ID #: 263HV106
• Status: Completed
• Phase: Phase 1
• Start date: October 2, 2019
• Est. completion date: December 27, 2019

Study information

• Verified date: March 2021
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered 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: December 27, 2019
• Est. primary completion date: December 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• 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:

• Suicide attempt within the last 2 years. Participants who, in the Investigator's judgment, pose a significant suicide risk or who have suicidal ideation associated with actual intent and a method or plan in the past 6 months (i.e., "Yes" answers on items 4 or 5 of the Columbia Suicide Severity Rating Scale) will be excluded from the study.

Note: Other protocol specific inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

• Healthy Volunteers

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	Long Beach	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 of BIIB104		pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Primary	Time to Reach Maximum Observed Concentration of BIIB104		pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Primary	Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau) of BIIB104		pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Primary	Maximum Observed Concentration at Steady State of BIIIB104		pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Primary	Time to Reach Maximum Observed Concentration at Steady State of BIIB104		pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Primary	Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State of BIIB104		pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Primary	Apparent Total Body Clearance of BIIB104		pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Primary	Apparent Volume of Distribution of BIIB104		pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Primary	Elimination Half-Life of BIIB104		pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Primary	Accumulation Ratio at Steady State of BIIB104		pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Primary	Trough Concentration of BIIB104		pre-dose on Day 1, 2, 4, 7, 10; 0.25 hour (h), 0.5h, 0.75h, 1h, 1.5h, 2h, 3h, 4h, 8h and 12h post-dose on Day 1 and 10 ; 1.5h post-dose on Day 4 and 7; Day 11
Secondary	Number of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.	Baseline (Day 1) up to Day 14
Secondary	Number of Participants With Serious Adverse Events (SAEs)	An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, 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.	Screening up to Day 14