A Phase 1 interventional study of BIIB122 and Rabeprazole in Healthy Volunteer, sponsored by Biogen. Completed at 1 site in United States. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-19.
Sponsored by Biogen · Phase 1, Interventional, and Treatment
The primary objective of the study is to evaluate the effects of a proton pump inhibitor (PPI) [rabeprazole] on BIIB122 pharmacokinetics (PK) after a single dose in healthy participants. The secondary objective of the study is to evaluate the safety and tolerability of BIIB122, with and without a PPI (rabeprazole), after a single dose in healthy participants.
Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Participants will receive a single oral dose of BIIB122, while fasting, followed by a washout period.
Drug: BIIB122
Participants will receive PPI pretreatment (rabeprazole) once daily (QD), followed by a single oral dose of BIIB122 while fasting, followed by a washout period.
Drug: BIIB122 · Drug: Rabeprazole
Participants will receive PPI pretreatment (rabeprazole) QD, followed by a single oral dose of BIIB122 while fed, followed by a washout period.
Drug: BIIB122 · Drug: Rabeprazole
Administered as specified in the treatment arm.
Also known as: DNL151
Administered as specified in the treatment arm.
Maximum Observed Concentration (Cmax) of BIIB122
Time frame: Up to Day 55
Area Under the Concentration-Time Curve From Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB122
Time frame: Up to Day 55
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinf) of BIIB122
Time frame: Up to Day 55
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 55
Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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