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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Study participants enrolled and randomized to this arm will receive a single dose of UCB0599 in 3 different formulations according to a pre-specified sequence during both Treatment Periods in the absence of esomeprazole, and the Treatment Periods in the presence of esomeprazole. |
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| Part B | Experimental | Study participants enrolled to this arm will receive pre-specified doses of UCB0599 or Placebo in a pre-specified sequence during the Treatment Period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB0599 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of UCB0599 in Part A | Cmax was maximum (peak) observed drug concentration following a single dose administration of UCB0599 under normal and elevated gastric pH condition. | 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 |
| Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 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. | 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 |
| Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC Inf) of UCB0599 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. | 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 |
| Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B | 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. | From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15) |
| Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part A | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Up0073 10001 | Glendale | California | 91206 | United States |
Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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The Participant Flow refers to the Randomized Set Part A and Randomized Set Part B. Part A: P1, P2, P3, P4, P5, and P6 refer to period 1 to 6.
The study started to enroll participants in May 2023 and concluded in April 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Treatment Sequence: ABC | Participants received a single dose of UCB0599 180 milligrams (mg) capsule (reference) (Treatment A) under fasting conditions on Day 1 in Period (P) 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Periods 4, 5, and 6 (elevated gastric pH), esomeprazole 40 mg was coadministered once daily from Day 14 to Day 33. Each treatment period was followed by a 4-day Washout period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A: P1 (Day 1, Normal Gastric pH) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 26, 2023 | Nov 24, 2025 |
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Part A of the study is following a full crossover design and Part B is a parallel design with crossover character referring to the dose levels.
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Part A is open-label and Part B double-blind (Participants will be blinded to the treatment (ie, UCB0599 or Placebo), but not to the dosage).
| Esomeprazole | Other | 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. |
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| Placebo | Other | Study participants will receive placebo comparator administered orally in a a pre-specified sequence during the Treatment Period of Part B. |
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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:
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| From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15) |
| Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B | : 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. | From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15) |
| Maximum Plasma Concentration (Cmax) of UCB0599 in Part B | Cmax was maximum (peak) observed drug concentration following a single dose administration of UCB0599. | 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 |
| Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part B | AUC(0-t) was area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of UCB0599. | 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 |
| Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC (Inf)) of UCB0599 in Part B | AUC inf was area under the plasma concentration-time curve from time 0 to infinity of UCB0599. | 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 |
| From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39) |
| Percentage of Study Participants With Serious Treatment-emergent Adverse Events (TEAEs) in Part A | 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:
| From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39) |
| Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part A | From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39) |
| FG001 | Part A: Treatment Sequence: ACB | Participants received a single dose of UCB0599 180 mg capsule (reference) (Treatment A) under fasting conditions on Day 1 in Period 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Periods 4, 5, and 6 (elevated gastric pH), esomeprazole 40 mg was coadministered once daily from Day 14 to Day 33. Each treatment period was followed by a 4-day Washout period. |
| FG002 | Part A: Treatment Sequence: BCA | Participants received a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 1 in Period 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg capsule (Treatment A) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Periods 4, 5, and 6 (elevated gastric pH), esomeprazole 40 mg was coadministered once daily from Day 14 to Day 33. Each treatment period was followed by a 4-day Washout period. |
| FG003 | Part A: Treatment Sequence: BAC | Participants received a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 1 in Period 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg capsule under fasting conditions (Treatment A) on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Period 4,5 and 6 (elevated gastric pH) esomeprazole 40 mg once daily was coadministered from day 14 to 33. Each treatment period was followed by a 4-day Washout Period. |
| FG004 | Part A: Treatment Sequence: CAB | Participants received a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 1 in Period 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg capsule (Treatment A) under fasting conditions on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Periods 4, 5, and 6 (elevated gastric pH), esomeprazole 40 mg was coadministered once daily from Day 14 to Day 33. Each treatment period was followed by a 4-day Washout period. |
| FG005 | Part A: Treatment Sequence: CBA | Participants received a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 1 in Period 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg capsule (Treatment A) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Periods 4, 5, and 6 (elevated gastric pH), esomeprazole 40 mg was coadministered once daily from Day 14 to Day 33. Each treatment period was followed by a 4-day Washout period. |
| FG006 | Part B: Treatment Sequence: Placebo 90 mg/Placebo 180 mg | Participants received a single dose of UCB0599 matching placebo 90 mg capsule on Day 1 in Period 1, followed by a single dose of UCB0599 matching placebo 180 mg capsule on Day 6 in Period 2 under fasting conditions. Periods 1 and 2 were separated by a washout period of 4 days. |
| FG007 | Part B: Treatment Sequence: UCB0599 90 mg/UCB0599 180 mg | Participants received a single dose of UCB0599 90 mg capsule on Day 1 in Period 1 followed by a single dose of UCB0599 180 mg capsule on Day 6 in Period 2 under fasting conditions. Periods 1 and 2 were separated by a wash out period of 4 days. |
| FG008 | Part B: Treatment Sequence: Placebo 180 mg/Placebo 360 mg | Participants received a single dose of UCB0599 matching placebo 180 mg capsule on Day 1 in Period 1 followed by a single dose of UCB0599 matching placebo 360 mg capsule on Day 6 in Period 2 under fasting conditions. Periods 1 and 2 were separated by a wash out period of 4 days. |
| FG009 | Part B: Treatment Sequence: UCB0599 180 mg/ UCB0599 360 mg | Participants received a single dose of UCB0599 180 mg capsule on Day 1 in Period 1 followed by a single dose of UCB0599 360 mg capsule on Day 6 in Period 2 under fasting conditions. Periods 1 and 2 were separated by a wash out period of 4 days. |
| FG010 | Part B: Treatment Sequence:Placebo 360 mg/Placebo 90 mg | Participants received a single dose of UCB0599 matching placebo 360 mg capsule on Day 1 in Period 1 followed by a single dose of UCB0599 matching placebo 90 mg capsule on Day 6 in Period 2 under fasting conditions. Periods 1 and 2 were separated by a wash out period of 4 days. |
| FG011 | Part B: Treatment Sequence: UCB0599 360 mg/ UCB0599 90 mg | Participants received a single dose of UCB0599 360 mg capsule on Day 1 in Period 1 followed by a single dose of UCB0599 90 mg capsule on Day 6 in Period 2 under fasting conditions. Periods 1 and 2 were separated by a wash out period of 4 days. |
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| Part A: P2 (Day 6, Normal Gastric pH) |
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| Part A: P3 (Day 11, Normal Gastric pH) |
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| Part A: P4 (Day 19,Elevated Gastric pH) |
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| Part A: P5 (Day 24,Elevated Gastric pH) |
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| Part A: P6 (Day 29,Elevated Gastric pH) |
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| Part B- Period 1 (Day 1) |
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| Part B- Period 2 (Day 6) |
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Safety Sets (Part A & B) included all study participants who were randomized and received full or partial study medication according to the treatment that the participants actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Treatment Sequence: ABC | Participants received a single dose of UCB0599 180 milligrams (mg) capsule (reference) (Treatment A) under fasting conditions on Day 1 in Period (P) 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Periods 4, 5, and 6 (elevated gastric pH), esomeprazole 40 mg was coadministered once daily from Day 14 to Day 33. Each treatment period was followed by a 4-day Washout period. |
| BG001 | Part A: Treatment Sequence: ACB | Participants received a single dose of UCB0599 180 mg capsule (reference) (Treatment A) under fasting conditions on Day 1 in Period 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Periods 4, 5, and 6 (elevated gastric pH), esomeprazole 40 mg was coadministered once daily from Day 14 to Day 33. Each treatment period was followed by a 4-day Washout period. |
| BG002 | Part A: Treatment Sequence: BCA | Participants received a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 1 in Period 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg capsule (Treatment A) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Periods 4, 5, and 6 (elevated gastric pH), esomeprazole 40 mg was coadministered once daily from Day 14 to Day 33. Each treatment period was followed by a 4-day Washout period. |
| BG003 | Part A: Treatment Sequence: BAC | Participants received a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 1 in Period 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg capsule under fasting conditions (Treatment A) on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Period 4,5 and 6 (elevated gastric pH) esomeprazole 40 mg once daily was coadministered from day 14 to 33. Each treatment period was followed by a 4-day Washout Period. |
| BG004 | Part A: Treatment Sequence: CAB | Participants received a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 1 in Period 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg capsule (Treatment A) under fasting conditions on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Periods 4, 5, and 6 (elevated gastric pH), esomeprazole 40 mg was coadministered once daily from Day 14 to Day 33. Each treatment period was followed by a 4-day Washout period. |
| BG005 | Part A: Treatment Sequence: CBA | Participants received a single dose of UCB0599 180 mg encapsulated tablet (Treatment C) under fasting conditions on Day 1 in Period 1 (normal gastric pH) and Day 19 in Period 4 (elevated gastric pH), followed by a single dose of UCB0599 180 mg non-encapsulated tablet (Treatment B) under fasting conditions on Day 6 in Period 2 (normal gastric pH) and Day 24 in Period 5 (elevated gastric pH), further followed by a single dose of UCB0599 180 mg capsule (Treatment A) under fasting conditions on Day 11 in Period 3 (normal gastric pH) and Day 29 in Period 6 (elevated gastric pH). In Periods 4, 5, and 6 (elevated gastric pH), esomeprazole 40 mg was coadministered once daily from Day 14 to Day 33. Each treatment period was followed by a 4-day Washout period. |
| BG006 | Part B: Treatment Sequence: Pooled Placebo | Participants received UCB0599 matching placebo, 90 mg capsule, on Day 1 in Period 1 followed by UCB0599 matching placebo, 180 mg capsule, on Day 6 in Period 2; received UCB0599 matching placebo, 180 mg capsule, on Day 1 in Period 1 followed by UCB0599 matching placebo, 360 mg capsule, on Day 6 in Period 2; and UCB0599 matching placebo, 360 mg capsule, on Day 1 in Period 1 followed by UCB0599 matching placebo, 90 mg capsule, on Day 6 in Period 2. Arm sequences were pooled for placebo in Part B. |
| BG007 | Part B: Treatment Sequence: UCB0599 90mg/UCB0599 180 mg | received a single dose of UCB0599 90 mg capsule on Day 1 in Period 1 followed by a single dose of UCB0599 180 mg capsule on Day 6 in Period 2 under fasting conditions. Periods 1 and 2 were separated by a wash out period of 4 days. |
| BG008 | Part B: Treatment Sequence: UCB0599 180 mg/ UCB0599 360 mg | Participants received a single dose of UCB0599 180 mg capsule on Day 1 in Period 1 followed by a single dose of UCB0599 360 mg capsule on Day 6 in Period 2 under fasting conditions. Periods 1 and 2 were separated by a wash out period of 4 days. |
| BG009 | Part B: Treatment Sequence: UCB0599 360mg/ UCB0599 90mg | Participants received UCB0599 360 mg capsule, on Day 1 in Period 1 followed by UCB0599 90 mg capsule, on Day 6 in Period 2. |
| BG010 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Maximum Plasma Concentration (Cmax) of UCB0599 in Part A | Cmax was maximum (peak) observed drug concentration following a single dose administration of UCB0599 under normal and elevated gastric pH condition. | Pharmacokinetic Set Part A (PKS A) included all randomized participants who received at least 1 total dose of study medication and have at least 1 observable PK measurement. Here, "number analyzed" signifies participants who were evaluable for specified categories. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | 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 |
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| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 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. | PKS A included all randomized participants who received at least 1 total dose of study medication and have at least 1 observable PK measurement. Here, "number analyzed" signifies participants who were evaluable for specified categories. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour nanograms per milliliter (h*ng/mL) | 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 |
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| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC Inf) of UCB0599 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. | PKS A included all randomized participants who received at least 1 total dose of study medication and have at least 1 observable PK measurement. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified categories. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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 |
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| Primary | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B | 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. | Safety Set Part B (SS B) included all study participants who were randomized and received full or partial study medication according to the treatment that the participants actually received. | Posted | Number | percentage of participants | From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15) |
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| Primary | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B | 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:
| SS B included all study participants who were randomized and received full or partial study medication according to the treatment that the participants actually received. | Posted | Number | percentage of participants | From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15) |
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| Primary | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B | : 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. | SS B included all study participants who were randomized and received full or partial study medication according to the treatment that the participants actually received. | Posted | Number | percentage of participants | From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15) |
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| Primary | Maximum Plasma Concentration (Cmax) of UCB0599 in Part B | Cmax was maximum (peak) observed drug concentration following a single dose administration of UCB0599. | Pharmacokinetic Set Part B (PKS B) included randomized participants who received at least 1 total dose of study medication and have at least 1 observable PK measurement. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
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| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part B | AUC(0-t) was area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of UCB0599. | The PKS B included randomized participants who received at least 1 total dose of study medication and have at least 1 observable PK measurement. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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 |
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| Primary | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC (Inf)) of UCB0599 in Part B | AUC inf was area under the plasma concentration-time curve from time 0 to infinity of UCB0599. | The PKS B included randomized participants who received at least 1 total dose of study medication and have at least 1 observable PK measurement. Here, "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | 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 |
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| Secondary | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part A | 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. | Safety Set Part A (SS A) included all study participants who were randomized and received full or partial study medication according to the treatment that the participants actually received. | Posted | Number | percentage of participants | From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39) |
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| Secondary | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (TEAEs) in Part A | 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:
| SS A included all study participants who were randomized and received full or partial study medication according to the treatment that the participants actually received. | Posted | Number | percentage of participants | From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39) |
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| Secondary | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part A | SS A included all study participants who were randomized and received full or partial study medication according to the treatment that the participants actually received. | Posted | Number | percentage of participants | From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39) |
|
For Part A: From Baseline (Day 1) of Part A until Safety Follow-Up (up to Day 39) and for Part B: From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15)
Treatment emergent AEs (TEAE): all AEs starting on/after the date/time of first treatment & up to including 4 days after last treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. Safety Sets (Part A & B) included All study participants who were randomized and received full or partial study medication according to the treatment that the participants actually received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: UCB0599 180 mg/Day Capsules | All participants who received a single dose of UCB0599 180 mg capsule under fasting conditions on Day 1 in Period 1 (normal gastric pH), Day 19 in Period 4 (elevated gastric pH), Day 11 in Period 3 (normal gastric pH), Day 29 in Period 6 (elevated gastric pH), Day 6 in Period 2 (normal gastric pH), and Day 24 in Period 5 (elevated gastric pH). Esomeprazole was coadministered with UCB0599 180 mg capsule in Treatment Periods 4, 5, and 6 (elevated gastric pH). | 0 | 42 | 0 | 42 | 5 | 42 |
| EG001 | Part A: UCB0599: Non-encapsulated Tablet 180 mg | All participants who received a single dose of UCB0599 180 mg non-encapsulated tablet under fasting conditions on Day 1 in Period 1 (normal gastric pH), Day 19 in Period 4 (elevated gastric pH), Day 6 in Period 2 (normal gastric pH), Day 24 in Period 5 (elevated gastric pH), Day 11 in Period 3 (normal gastric pH), and Day 29 in Period 6 (elevated gastric pH). Esomeprazole was coadministered with UCB0599 180 mg non-encapsulated tablet in Treatment Periods 4, 5, and 6 (elevated gastric pH). | 0 | 42 | 0 | 42 | 11 | 42 |
| EG002 | Part A: UCB0599 180 mg/Day Encapsulated Tablets | All participants who received a single dose of UCB0599 180 mg encapsulated tablet under fasting conditions on Day 1 in Period 1 (normal gastric pH), Day 19 in Period 4 (elevated gastric pH), Day 6 in Period 2 (normal gastric pH), Day 24 in Period 5 (elevated gastric pH), Day 11 in Period 3 (normal gastric pH), and Day 29 in Period 6 (elevated gastric pH). Esomeprazole was coadministered with UCB0599 180 mg encapsulated tablet in Treatment Periods 4, 5, and 6 (elevated gastric pH). | 0 | 42 | 0 | 42 | 6 | 42 |
| EG003 | Part B: Pooled Placebo (Japanese Participants) | All the Japanese participants who received placebo (matching to UCB0599 90 mg, 180 mg, 360 mg) on Day 1 of Period 1 and Day 6 of Period 2. Pooled data is reported for the placebo group. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG004 | Part B: UCB0599 90 mg (Japanese Participants) | Japanese participants who received a single dose of UCB0599 90 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG005 | Part B: UCB0599 180 mg (Japanese Participants) | Japanese participants who received a single dose of UCB0599 180 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG006 | Part B: UCB0599 360mg (Japanese Participants) | Japanese participants who received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG007 | Part B: Pooled Placebo (Chinese Participants) | All the Chinese participants who received placebo (matching to UCB0599 90 mg, 180 mg, 360 mg) on Day 1 of Period 1 and Day 6 of Period 2. Pooled data is reported for the placebo group. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG008 | Part B: UCB0599 90 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 90 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG009 | Part B: UCB0599 180 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 180 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. | 0 | 9 | 0 | 9 | 3 | 9 |
| EG010 | Part B: UCB0599 360 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. | 0 | 8 | 0 | 8 | 2 | 8 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | 001 844 599 2273 | UCBCares@ucb.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 5, 2023 | Nov 24, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Black |
|
| Native Hawaiian or other Pacific Islander |
|
| White |
|
| Other or Mixed |
|
| Not Hispanic or Latino |
|
| Elevated |
|
|
For Normal gastric pH
| GLSM ratio |
| 0.7053 |
| 2-Sided |
| 90 |
| 0.6427 |
| 0.7741 |
The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg. |
| Other |
| For Normal gastric pH | GLSM ratio | 0.8529 | 2-Sided | 90 | 0.7771 | 0.9361 | The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Non-encapsulated tablet 180 mg. | Other |
| For Elevated gastric pH | GLSM ratio | 1.563 | 2-Sided | 90 | 1.376 | 1.776 | The GLSM ratio was calculated as UCB0599: Non-encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg. | Other |
| For Elevated gastric pH | GLSM ratio | 1.415 | 2-Sided | 90 | 1.248 | 1.604 | The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Capsule 180 mg. | Other |
| For Elevated gastric pH | GLSM ratio | 0.9050 | 2-Sided | 90 | 0.7972 | 1.027 | The GLSM ratio was calculated as UCB0599: Encapsulated tablet 180 mg divided by UCB0599: Non-encapsulated tablet 180 mg. | Other |
| OG002 | Part A: UCB0599: Encapsulated Tablet 180 mg | All participants who received a single dose of UCB0599 180 mg encapsulated tablet under fasting conditions on Day 1 in Period 1 (normal gastric pH), Day 19 in Period 4 (elevated gastric pH), Day 6 in Period 2 (normal gastric pH), Day 24 in Period 5 (elevated gastric pH), Day 11 in Period 3 (normal gastric pH), and Day 29 in Period 6 (elevated gastric pH). Esomeprazole was coadministered with UCB0599 180 mg encapsulated tablet in Treatment Periods 4, 5, and 6 (elevated gastric pH). |
|
|
|
| OG002 | Part A: UCB0599: Encapsulated Tablet 180 mg | All participants who received a single dose of UCB0599 180 mg encapsulated tablet under fasting conditions on Day 1 in Period 1 (normal gastric pH), Day 19 in Period 4 (elevated gastric pH), Day 6 in Period 2 (normal gastric pH), Day 24 in Period 5 (elevated gastric pH), Day 11 in Period 3 (normal gastric pH), and Day 29 in Period 6 (elevated gastric pH). Esomeprazole was coadministered with UCB0599 180 mg encapsulated tablet in Treatment Periods 4, 5, and 6 (elevated gastric pH). |
|
|
|
| OG002 |
| Part B: UCB0599 180 mg (Japanese Participants) |
Japanese participants who received a single dose of UCB0599 180 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG003 | Part B: UCB0599 360 mg (Japanese Participants) | Japanese participants who received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG004 | Part B: Pooled Placebo (Chinese Participants) | All the Chinese participants who received placebo (matching to UCB0599 90 mg, 180 mg, 360 mg) on Day 1 of Period 1 and Day 6 of Period 2. Pooled data is reported for the placebo group. |
| OG005 | Part B: UCB0599 90 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 90 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG006 | Part B: UCB0599 180 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 180 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG007 | Part B: UCB0599 360 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
|
|
| OG002 |
| Part B: UCB0599 180 mg (Japanese Participants) |
Japanese participants who received a single dose of UCB0599 180 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG003 | Part B: UCB0599 360 mg (Japanese Participants) | Japanese participants who received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG004 | Part B: Pooled Placebo (Chinese Participants) | All the Chinese participants who received placebo (matching to UCB0599 90 mg, 180 mg, 360 mg) on Day 1 of Period 1 and Day 6 of Period 2. Pooled data is reported for the placebo group. |
| OG005 | Part B: UCB0599 90 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 90 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG006 | Part B: UCB0599 180 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 180 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG007 | Part B: UCB0599 360 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
|
|
| OG002 |
| Part B: UCB0599 180 mg (Japanese Participants) |
Japanese participants who received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG003 | Part B: UCB0599 360 mg (Japanese Participants) | Japanese participants who received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG004 | Part B: Pooled Placebo (Chinese Participants) | All the Chinese participants who received placebo (matching to UCB0599 90 mg, 180 mg, 360 mg) on Day 1 of Period 1 and Day 6 of Period 2. Pooled data is reported for the placebo group. |
| OG005 | Part B: UCB0599 90 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 90 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG006 | Part B: UCB0599 180 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 180 mg capsule Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG007 | Part B: UCB0599 360 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
|
|
| OG003 | Part B: UCB0599 90 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 90 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG004 | Part B: UCB0599 180 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 180 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG005 | Part B: UCB0599 360 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
|
|
| OG003 | Part B: UCB0599 90 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 90 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG004 | Part B: UCB0599 180 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 180 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG005 | Part B: UCB0599 360 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
|
|
Japanese participants who received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days.
| OG003 | Part B: UCB0599 90 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 90 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG004 | Part B: UCB0599 180 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 180 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
| OG005 | Part B: UCB0599 360 mg (Chinese Participants) | Chinese participants received a single dose of UCB0599 360 mg capsule on Day 1 of Period 1 and Day 6 of Period 2. Period 1 and Period 2 were separated by a washout period of 4 days. |
|
|
| OG002 | Part A: UCB0599: Encapsulated Tablet 180 mg | All participants who received a single dose of UCB0599 180 mg encapsulated tablet under fasting conditions on Day 1 in Period 1 (normal gastric pH), Day 19 in Period 4 (elevated gastric pH), Day 6 in Period 2 (normal gastric pH), Day 24 in Period 5 (elevated gastric pH), Day 11 in Period 3 (normal gastric pH), and Day 29 in Period 6 (elevated gastric pH). Esomeprazole was coadministered with UCB0599 180 mg encapsulated tablet in Treatment Periods 4, 5, and 6 (elevated gastric pH). |
|
|
All participants who received a single dose of UCB0599 180 mg non-encapsulated tablet under fasting conditions on Day 1 in Period 1 (normal gastric pH), Day 19 in Period 4 (elevated gastric pH), Day 6 in Period 2 (normal gastric pH), Day 24 in Period 5 (elevated gastric pH), Day 11 in Period 3 (normal gastric pH), and Day 29 in Period 6 (elevated gastric pH). Esomeprazole was coadministered with UCB0599 180 mg non-encapsulated tablet in Treatment Periods 4, 5, and 6 (elevated gastric pH).
| OG002 | Part A: UCB0599: Encapsulated Tablet 180 mg | All participants who received a single dose of UCB0599 180 mg encapsulated tablet under fasting conditions on Day 1 in Period 1 (normal gastric pH), Day 19 in Period 4 (elevated gastric pH), Day 6 in Period 2 (normal gastric pH), Day 24 in Period 5 (elevated gastric pH), Day 11 in Period 3 (normal gastric pH), and Day 29 in Period 6 (elevated gastric pH). Esomeprazole was coadministered with UCB0599 180 mg encapsulated tablet in Treatment Periods 4, 5, and 6 (elevated gastric pH). |
|
|
| OG002 | Part A: UCB0599: Encapsulated Tablet 180 mg | All participants who received a single dose of UCB0599 180 mg encapsulated tablet under fasting conditions on Day 1 in Period 1 (normal gastric pH), Day 19 in Period 4 (elevated gastric pH), Day 6 in Period 2 (normal gastric pH), Day 24 in Period 5 (elevated gastric pH), Day 11 in Period 3 (normal gastric pH), and Day 29 in Period 6 (elevated gastric pH). Esomeprazole was coadministered with UCB0599 180 mg encapsulated tablet in Treatment Periods 4, 5, and 6 (elevated gastric pH). |
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