Research Site
Daytona Beach, Florida, 32117, United States
NCT Number: NCT02951221
The primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Daytona Beach, Florida, 32117, 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
Lower dose RCF fasted
Lower dose DCF fasted
Higher dose DCF fasted
Higher dose DCF fed
Time frame: Day 1, 2, 3, 8, 9, 10
Time frame: Day 1, 2, 3, 8, 9, 10
Time frame: Day 1, 2, 3, 8, 9, 10
Time frame: Day 1, 2, 3, 8, 9, 10
Time frame: Day 1, 2, 3, 8, 9, 10
Time frame: Day 1, 2, 3, 8, 9, 10
Time frame: Up to Day 18
Time frame: Up to Day 10
Time frame: Up to Day 10
Time frame: Up to Day 10
Time frame: Up to Day 10
Biogen
Industry
A Phase 1, Open-label Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB074 and to Assess the Effect of Food on BIIB074 Pharmacokinetics in Healthy Subjects
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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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