UP0159 1
San Antonio, Texas, 78209, United States
NCT Number: NCT07220551
The purpose of this study is to estimate the relative bioavailability of UCB0022 Formulation 2 (Test) versus Formulation 1 (Reference) in healthy participants following single oral administration.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
San Antonio, Texas, 78209, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, or alkaline phosphatase (ALP) >1.0×upper limit of normal (ULN) (isolated bilirubin <1.5×ULN is acceptable if fractionated and direct bilirubin <35%).
Participants will receive a single oral dose of UCB0022 tablet Formulation 1 and UCB0022 tablet Formulation 2 following a pre-specified sequence.
Other names: Glovadalen
Time frame: From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2
AUC: Area under the plasma concentration-time curve.
Time frame: From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2
AUC0-t: Area under the plasma concentration-time curve from time 0 to t.
Time frame: From Day 1 (Predose) up to Day 14 of Period 1 and from Day 15 (Predose) up to Day 28 of Period 2
Cmax: Maximum observed plasma concentration.
Time frame: From Dosing (Day 1) up to SFU period or End of study (EOS) (up to Day 28)
A TEAE is defined as any AE with a start date or time on or after the first dose of study intervention until the end of the SFU Period (ie, EOS/SFU Visit).
UCB Biopharma SRL
Industry
An Open-Label, Single-Center, Randomized, 2-Way Crossover Study to Evaluate the Relative Bioavailability and Safety of Two UCB0022 Tablet Formulations in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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