This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK).
Initial protocol recruitment and follow up was completed by 10 Jan 2020 with an optional cohort intended for completion by April 2020. Subsequently, a decision was made not to progress this optional cohort in light of COVID-19 which has resulted in a delay in reporting the actual completion date.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Research Site
Dallas, Texas, United States
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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. An 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), however, this does not include an event that, had it occurred in a more severe form, might have caused 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.
Time frame: Baseline up to Day 9 for SAD Cohorts; Baseline up to Day 24 for MAD Cohorts
Area Under the Curve from Time 0 to the Time of the Last Measurable Concentration (AUClast)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)
Time frame: Baseline and multiple timepoints up to Day 3
Maximum Observed Concentration (Cmax)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts
Time to Reach Maximum Observed Concentration (Tmax)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 14 for MAD Cohorts
Elimination Half-Life (t½)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Apparent Total Body Clearance (CL/F)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F)
Time frame: Baseline and multiple timepoints up to Day 3 for SAD Cohorts; Baseline and multiple timepoints up to Day 16 for MAD Cohorts
Amount of BIIB091 Excreted in Urine per Sampling Interval (Aeu)
Time frame: Baseline and multiple timepoints up to Day 3
Percentage of BIIB091 Excreted in Urine per Sampling Interval (%Feu)
Time frame: Baseline and multiple timepoints up to Day 3
Renal clearance (CLr)
Time frame: Baseline and multiple timepoints up to Day 3
Area Under the Concentration-Time Curve Within a Dosing Interval (AUCtau)
Time frame: Baseline and multiple timepoints up to Day 16
Accumulation Ratio (R)
Time frame: Baseline and multiple timepoints up to Day 16
Trough concentration (Ctrough)
Time frame: Baseline and multiple timepoints up to Day 16