Up0073 10001
Glendale, California, 91206, United States
NCT Number: NCT05845645
The purpose of the study is to estimate the relative bioavailability of 2 new UCB0599 formulations under elevated and normal gastric pH conditions in healthy participants (Part A) and to asess the safety, tolerability and pharmacokinetics of UCB0599 in healthy participants of Japanese and Chinese origins (Part B).
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Glendale, California, 91206, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study participants will receive pre-specified doses of UCB0599 in 3 different formulations administered orally in a pre-specified sequence during the Treatment Periods of Part A and B
Study participants will receive fixed dose of esomeprazole administered orally in a pre-specified sequence during the Treatment Period of Part A. This is a non-investigational medicinal product (NIMP) in this study.
Study participants will receive placebo comparator administered orally in a a pre-specified sequence during the Treatment Period of Part B.
Other names: PBO
Time frame: Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, 6, 11, 19, 24 and 29 in Part A
Cmax was maximum (peak) observed drug concentration following a single dose administration of UCB0599 under normal and elevated gastric pH condition.
Time frame: Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, 6, 11, 19, 24 and 29 in Part A
AUC(0-t) was area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of UCB0599 under normal and elevated gastric pH condition.
Time frame: Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, 6, 11, 19, 24 and 29 in Part A
AUC inf was area under the plasma concentration-time curve from time 0 to infinity of UCB0599 under normal and elevated gastric pH condition.
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15)
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as AEs starting on/after the date/time of first treatment & upto including 4 days after last treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment.
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15)
Serious TEAEs were any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment and additionally were emergent untoward medical occurrence that at any dose:
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15)
: An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as AEs starting on/after the date/time of first treatment & upto including 4 days after last treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment.
Time frame: Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, and 6 in Part B
Cmax was maximum (peak) observed drug concentration following a single dose administration of UCB0599.
Time frame: Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, and 6 in Part B
AUC(0-t) was area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of UCB0599.
Time frame: Predose and at 0.25, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, 48, 72, and 96 hours after UCB0599 administration on Days 1, and 6 in Part B
AUC inf was area under the plasma concentration-time curve from time 0 to infinity of UCB0599.
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as AEs starting on/after the date/time of first treatment & upto including 4 days after last treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment.
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)
Serious TEAEs were any untoward medical incidence in a participant during administered study treatment, whether or not these events were related to study treatment and additionally were emergent untoward medical occurrence that at any dose:
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)
UCB Biopharma SRL
Industry
A 2-Part Study to Evaluate the Relative Bioavailability of 2 New Formulations of UCB0599 and the Effect of Esomeprazole on the PK of UCB0599 in Healthy Participants (Part A, Open-Label) and to Assess the Safety/Tolerability and PK of UCB0599 in Healthy Participants of Japanese and Chinese Origins (Part B, Double-Blind)
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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