Research Site
Dallas, Texas, 75247, United States
NCT Number: NCT03385525
The primary objective of this study is to evaluate the effect of multiple doses of the UGT inhibitor valproic acid on the single-dose pharmacokinetics of BIIB074. The secondary objectives of this study are to evaluate the safety and tolerability of BIIB074 when administered alone and when coadministered with the UGT inhibitor valproic acid and to evaluate the effect of the UGT inhibitor valproic acid on the PK of the M13, M14, and M16 metabolites of BIIB074.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Dallas, Texas, 75247, 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
Administered as specified in the treatment arm
Other names: Depakote, Depakene, Stavzor, and Valproic
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Up to Day 32
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Time frame: Day 1, 3, 8, 13, 16, 18, 23
Time frame: Day 3, 8, 13, 16, 18, 23
Time frame: Day 1, 3, 8, 13, 16, 18, 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 1 through Day 8, Day 16 through Day 23
Time frame: Day 8, 23, and once between Day 29-32
C-SSRS is a suicidal ideation rating used to evaluate suicidality in children ages 12 and up. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent
Biogen
Industry
A Phase 1, Open-label, Fixed-sequence Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074 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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