Clinical Trial: New Formulation and Food Effect Study of BIIB074

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary:
Sponsor: Biogen

Current Primary Outcome:

  • PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax) [ Time Frame: Day 1, 2, 3, 8, 9, 10 ]
  • PK of BIIB074 DCF to RCF as assessed by area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUClast) [ Time Frame: Day 1, 2, 3, 8, 9, 10 ]
  • PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞) [ Time Frame: Day 1, 2, 3, 8, 9, 10 ]
  • PK of BIIB074 DCF as assessed by Cmax [ Time Frame: Day 1, 2, 3, 8, 9, 10 ]
  • PK of BIIB074 DCF as assessed by AUClast [ Time Frame: Day 1, 2, 3, 8, 9, 10 ]
  • PK of BIIB074 DCF as assessed by AUC∞ [ Time Frame: Day 1, 2, 3, 8, 9, 10 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 18 ]
  • Number of participants with clinically significant laboratory assessment abnormalities [ Time Frame: Up to Day 10 ]
  • Number of participants with clinically significant vital sign abnormalities [ Time Frame: Up to Day 10 ]
  • Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities [ Time Frame: Up to Day 10 ]
  • Number of participants with clinically significant physical examinations abnormalities [ Time Frame: Up to Day 10 ]


Original Secondary Outcome: Same as current

Information By: Biogen

Dates:
Date Received: October 24, 2016
Date Started: December 2016
Date Completion:
Last Updated: February 23, 2017
Last Verified: February 2017