A Phase 1 interventional study of BIIB104 Reference Formulation and BIIB104 Test Formulation in Healthy Volunteers, sponsored by Biogen. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Biogen · Phase 1, Interventional, and Treatment
The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for the test formulation in healthy Caucasian male adult participants.
The secondary objective of the study is to assess the safety and tolerability of BIIB104 0.5 milligrams (mg) test formulation in the fasted and fed states following single-dose administration.
Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 49 (49%) 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 BIIB104 0.5 mg, immediate-release liquid-filled hard-shell capsule, orally, on Day 1 in the fasted state.
Drug: BIIB104 Reference Formulation
Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fasted state.
Drug: BIIB104 Test Formulation
Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fed state.
Drug: BIIB104 Test Formulation
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Area Under the Plasma Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB104
Time frame: Up to Day 6
Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf) of BIIB104
Time frame: Up to Day 6
Maximum Observed Plasma Concentration (Cmax) of BIIB104
Time frame: Up to Day 6
Time to Reach Maximum Observed Plasma Concentration (Tmax) for BIIB104
Time frame: Up to Day 6
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs that start or worsen after receiving the study drug. An SAE is any untoward medical occurrence that at any dose results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event.
Time frame: From Day 1 up to end of study (up to Day 16)
Number of Participants with Clinically Significant Abnormalities in Clinical Laboratory Parameters
Time frame: From Day 1 up to end of study (up to Day 16)
Number of Participants with Clinically Significant Abnormalities in Vital Signs
Time frame: From Day 1 up to end of study (up to Day 16)
Number of Participants with Clinically Significant Abnormalities in Physical Examination Parameters
Time frame: From Day 1 up to end of study (up to Day 16)
Plan to share: Yes — In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Ran from Dec 2021 to primary completion in Jan 2022, 1 month.
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: PF-04958242