Research Site
Evansville, Indiana, 47710, United States
NCT Number: NCT02829541
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Evansville, Indiana, 47710, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Administered as specified in the treatment arm.
Other names: Bruton's tyrosine kinase (BTK)
Administered as specified in the treatment arm
Time frame: Up to 9 Days Post dose
Time frame: Up to 9 Days Post dose
Time frame: Up to 9 Days Post dose
Time frame: Up to 9 Days Post dose
Time frame: Up to 9 Days Post dose
Time frame: Up to 48 Hours Post dose
Time frame: Up to 48 Hours Post dose
Time frame: Up to 48 Hours Post dose
Time frame: Up to 48 Hours Post dose
Time frame: Up to 48 Hours Post dose
Time frame: Up to 48 Hours Post dose
Time frame: Up to 48 Hours Post dose
Time frame: Up to 48 Hours Post dose
Time frame: Up to 48 Hours Post dose
Time frame: Up to 48 Hours Post dose
Biogen
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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