A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy Participants



Status:Recruiting
Healthy:No
Age Range:18 - 55
Updated:12/3/2016
Start Date:July 2016
End Date:January 2017
Contact:Biogen
Email:clinicaltrials@biogen.com

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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

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.


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.
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