Clinical trial NCT02829541: A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy Participants
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB068, a Bruton's Tyrosine Kinase Inhibitor, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupos Erythematosus, SLE
Keywords: Single Ascending Dose (SAD), Healthy Volunteers
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-07-12
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants. Secondary objectives are to characterize the single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of BIIB068 in healthy participants.


Eligibility criteria: Key Inclusion Criteria:

* All male subjects must practice highly effective methods of contraception during the study and be willing and able to continue contraception and not donate sperm for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
* All female subjects of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for at least 1ovulatory cycle (30 days) after their last dose of study treatment.
* Must have a body mass index (BMI) between 18 and 32 kg/m2
* Must be in good health as determined by the Investigator, based on medical history and screening evaluations.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* History of severe allergic or anaphylactic reactions, or history of any allergic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
* Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day-1.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 9 Days Post dose
measure: Number of participants with clinically significant laboratory assessment abnormalities
timeFrame: Up to 9 Days Post dose
measure: Number of participants with clinically significant Vital sign abnormalities
timeFrame: Up to 9 Days Post dose
measure: Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
timeFrame: Up to 9 Days Post dose
measure: Number of participants with clinically significant physical examination abnormalities
timeFrame: Up to 9 Days Post dose
Secondary outcomes:
measure: PK Assessment - Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)
timeFrame: Up to 48 Hours Post dose
measure: PK Assessment - Area under the concentration-time curve from time 0 to infinity (AUCinf)
timeFrame: Up to 48 Hours Post dose
measure: PK Assessment - Maximum observed concentration (Cmax)
timeFrame: Up to 48 Hours Post dose
measure: PK Assessment - Time to reach maximum observed concentration (Tmax)
timeFrame: Up to 48 Hours Post dose
measure: PK Assessment - Terminal elimination half-life (t1/2)
timeFrame: Up to 48 Hours Post dose
measure: PK Assessment - Apparent total body clearance (CL/F)
timeFrame: Up to 48 Hours Post dose
measure: PK Assessment - Apparent volume of distribution (Vz/F)
timeFrame: Up to 48 Hours Post dose
measure: PK Assessment - Amount of BIIB068 excreted in urine (Aeu)
timeFrame: Up to 48 Hours Post dose
measure: PK Assessment - Percentage (%fe) of BIIB068 excreted in urine
timeFrame: Up to 48 Hours Post dose
measure: PK Assessment - Renal clearance (CLr)
timeFrame: Up to 48 Hours Post dose
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Research Site
state: Indiana
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: