Healthy Study Participants
Conditions
Keywords
Phase 1, Healthy Study Participants, UCB0599, Bioavailability study
Brief summary
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).
Interventions
DRUGUCB0599
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
OTHEREsomeprazole
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.
OTHERPlacebo
Study participants will receive placebo comparator administered orally in a a pre-specified sequence during the Treatment Period of Part B.
Sponsors
UCB Biopharma SRL
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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).
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Part A only: all healthy study participants except for those participants who are eligible for Part B of the study * For participants of Japanese origin (Part B): study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Japanese grandparents born in Japan). For participants of Chinese origin (Part B): study participant is of Chinese descent as evidenced by appearance and verbal confirmation of familial heritage (a participant has all 4 Chinese grandparents born in China). * Body weight within 45 to 100 kg (female) and 50 to 100 kg (male) and body mass index (BMI) within the range 18 to 30 kg/m\^2 (inclusive at screening) * Healthy male and female study participants
Exclusion criteria
* Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study * Participant has a history or presence of/significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data * Participant has had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell carcinomas that have been resected, squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * Participant has had breast cancer within the past 10 years * Participant has a history of alcohol or drug abuse within the last 1 year from Screening, as defined according to the Diagnostic and Statistical Manual of Mental Disorders * Participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol * Participant has a consumption of more than 600 mg of caffeine/day at screening and throughout the study * Participant has consumed any grapefruit, grapefruit juice, grapefruit-containing products, or star fruit within 14 days prior to administration of study medication or is not willing to refrain from consuming these products for the duration of the study * Participant has previously participated in this study or participant has previously been assigned to treatment in a study of the medication under investigation in this study * Participant has participated in another study of a study medication (and/or an investigational device) within the previous 30 days or 5 half-lives, whichever is greatest, or is currently participating in another study of an study medication (and/or an investigational device) * Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to dosing * Positive hepatitis C antibody test (HCVAb) result at screening or within 3 months prior to starting study intervention * Positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study medication * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) * For women of childbearing potential, study participant is pregnant, planning on becoming pregnant during the study, or is breastfeeding * Participants who may have a history of confirmed gastric ulceration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC (Inf)) of UCB0599 in Part B | 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. |
| Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B | 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. |
| Maximum Plasma Concentration (Cmax) of UCB0599 in Part B | 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. |
| Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part B | 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. |
| Maximum Plasma Concentration (Cmax) of UCB0599 in Part A | 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. |
| Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part A | 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. |
| Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC Inf) of UCB0599 in Part A | 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. |
| Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B | 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. |
| Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B | 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: 1. Results in death 2. Is life-threatening 3. Required in patient hospitalisation or prolongation of existing hospitalisation 4. Results in persistent disability/incapacity 5. Was a congenital anomaly or birth defect 6. Important medical events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Study Participants With Serious Treatment-emergent Adverse Events (TEAEs) in Part A | 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: 1. Results in death 2. Is life-threatening 3. Required in patient hospitalisation or prolongation of existing hospitalisation 4. Results in persistent disability/incapacity 5. Was a congenital anomaly or birth defect 6. Important medical events |
| 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) | — |
| Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part A | 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. |
Countries
United States
Participant flow
Recruitment details
The study started to enroll participants in May 2023 and concluded in April 2024.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 7 |
| 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. | 7 |
| 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. | 7 |
| 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. | 7 |
| 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. | 7 |
| 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. | 6 |
| 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. | 8 |
| 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. | 9 |
| 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. | 8 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A: P5 (Day 24,Elevated Gastric pH) | Consent Withdrawn (not due to adverse event) | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part B- Period 1 (Day 1) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Part A: Treatment Sequence: ACB | Part A: Treatment Sequence: BCA | Part A: Treatment Sequence: BAC | Part A: Treatment Sequence: CAB | Part A: Treatment Sequence: CBA | Part A: Treatment Sequence: ABC | Part B: Treatment Sequence: Pooled Placebo | Part B: Treatment Sequence: UCB0599 90mg/UCB0599 180 mg | Part B: Treatment Sequence: UCB0599 180 mg/ UCB0599 360 mg | Part B: Treatment Sequence: UCB0599 360mg/ UCB0599 90mg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 7 Participants | 7 Participants | 7 Participants | 7 Participants | 6 Participants | 8 Participants | 9 Participants | 8 Participants | 73 Participants |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 7.4 | 37.0 years STANDARD_DEVIATION 10.9 | 30.9 years STANDARD_DEVIATION 5.5 | 33.1 years STANDARD_DEVIATION 8.8 | 31.9 years STANDARD_DEVIATION 8.7 | 36.1 years STANDARD_DEVIATION 7.1 | 39.5 years STANDARD_DEVIATION 9.8 | 39.3 years STANDARD_DEVIATION 7.9 | 30.7 years STANDARD_DEVIATION 6.5 | 40.1 years STANDARD_DEVIATION 9 | 36.0 years STANDARD_DEVIATION 8.7 |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 8 Participants | 9 Participants | 8 Participants | 31 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 5 Participants | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 13 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 Participants | 3 Participants | 1 Participants | 3 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 16 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 4 Participants | 4 Participants | 6 Participants | 4 Participants | 4 Participants | 4 Participants | 6 Participants | 8 Participants | 9 Participants | 8 Participants | 57 Participants |
| Race/Ethnicity, Customized Other or Mixed | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 6 Participants | 6 Participants | 2 Participants | 5 Participants | 5 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 28 Participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 1 Participants | 3 Participants | 4 Participants | 4 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 27 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 6 Participants | 4 Participants | 3 Participants | 3 Participants | 5 Participants | 6 Participants | 8 Participants | 6 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 | 0 / 42 | 0 / 3 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 8 | 0 / 9 | 0 / 8 |
| other Total, other adverse events | 5 / 42 | 11 / 42 | 6 / 42 | 1 / 3 | 2 / 8 | 0 / 8 | 0 / 8 | 1 / 3 | 1 / 8 | 3 / 9 | 2 / 8 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 | 0 / 42 | 0 / 3 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 3 | 0 / 8 | 0 / 9 | 0 / 8 |
Outcome results
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.
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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC Inf) of UCB0599 in Part A | Normal | 5829 h*ng/mL | Geometric Coefficient of Variation 36.8 |
| Part A: UCB0599: Capsule 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC Inf) of UCB0599 in Part A | Elevated | 5538 h*ng/mL | Geometric Coefficient of Variation 49.5 |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC Inf) of UCB0599 in Part A | Normal | 5561 h*ng/mL | Geometric Coefficient of Variation 42.3 |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC Inf) of UCB0599 in Part A | Elevated | 5835 h*ng/mL | Geometric Coefficient of Variation 44.9 |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC Inf) of UCB0599 in Part A | Normal | 5374 h*ng/mL | Geometric Coefficient of Variation 44.5 |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC Inf) of UCB0599 in Part A | Elevated | 5720 h*ng/mL | Geometric Coefficient of Variation 41.4 |
Comparison: For Normal gastric pH90% CI: [0.9011, 1.006]
Comparison: For Normal gastric pH90% CI: [0.8762, 0.9777]
Comparison: For Normal gastric pH90% CI: [0.9204, 1.027]
Comparison: For Elevated gastric pH90% CI: [0.994, 1.116]
Comparison: For Elevated gastric pH90% CI: [0.971, 1.086]
Comparison: For Elevated gastric pH90% CI: [0.9208, 1.032]
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.
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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC (Inf)) of UCB0599 in Part B | 3425 h*ng/mL | Geometric Coefficient of Variation 29.6 |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC (Inf)) of UCB0599 in Part B | 5151 h*ng/mL | Geometric Coefficient of Variation 27.5 |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC (Inf)) of UCB0599 in Part B | 12100 h*ng/mL | Geometric Coefficient of Variation 36.7 |
| Part B: UCB0599 360 mg (Japanese Participants) | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC (Inf)) of UCB0599 in Part B | 3847 h*ng/mL | Geometric Coefficient of Variation 23.2 |
| Part B: Pooled Placebo (Chinese Participants) | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC (Inf)) of UCB0599 in Part B | 6741 h*ng/mL | Geometric Coefficient of Variation 28.5 |
| Part B: UCB0599 90 mg (Chinese Participants) | Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC (Inf)) of UCB0599 in Part B | 14070 h*ng/mL | Geometric Coefficient of Variation 25.1 |
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.
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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part A | Normal | 5774 hour nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 35.5 |
| Part A: UCB0599: Capsule 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part A | Elevated | 5489 hour nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 49.2 |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part A | Normal | 5503 hour nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 41 |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part A | Elevated | 5779 hour nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 43.9 |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part A | Normal | 5324 hour nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 43.1 |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part A | Elevated | 5641 hour nanograms per milliliter (h*ng/mL) | Geometric Coefficient of Variation 41.3 |
Comparison: For Normal gastric pH90% CI: [0.9052, 1.003]
Comparison: For Normal gastric pH90% CI: [0.8758, 0.9706]
Comparison: For Normal gastric pH90% CI: [0.9191, 1.019]
Comparison: For Elevated gastric pH90% CI: [1.001, 1.12]
Comparison: For Elevated gastric pH90% CI: [0.9826, 1.097]
Comparison: For Elevated gastric pH90% CI: [0.9273, 1.037]
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.
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
Population: The PKS B included randomized participants who received at least 1 total dose of study medication and have at least 1 observable PK measurement.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part B | 3363 h*ng/mL | Geometric Coefficient of Variation 29.5 |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part B | 5242 h*ng/mL | Geometric Coefficient of Variation 23.6 |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part B | 12010 h*ng/mL | Geometric Coefficient of Variation 36.5 |
| Part B: UCB0599 360 mg (Japanese Participants) | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part B | 3795 h*ng/mL | Geometric Coefficient of Variation 23.5 |
| Part B: Pooled Placebo (Chinese Participants) | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part B | 6689 h*ng/mL | Geometric Coefficient of Variation 28.6 |
| Part B: UCB0599 90 mg (Chinese Participants) | Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration (AUC(0-t)) of UCB0599 in Part B | 14020 h*ng/mL | Geometric Coefficient of Variation 25.2 |
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.
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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Maximum Plasma Concentration (Cmax) of UCB0599 in Part A | Normal | 876.2 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 30.2 |
| Part A: UCB0599: Capsule 180 mg | Maximum Plasma Concentration (Cmax) of UCB0599 in Part A | Elevated | 449.3 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 54.9 |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Maximum Plasma Concentration (Cmax) of UCB0599 in Part A | Normal | 724.6 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 39.4 |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Maximum Plasma Concentration (Cmax) of UCB0599 in Part A | Elevated | 694.4 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 43.8 |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Maximum Plasma Concentration (Cmax) of UCB0599 in Part A | Normal | 618.0 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 38.2 |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Maximum Plasma Concentration (Cmax) of UCB0599 in Part A | Elevated | 631.4 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 42.8 |
Comparison: For normal gastric pH90% CI: [0.7535, 0.9076]
Comparison: For Normal gastric pH90% CI: [0.6427, 0.7741]
Comparison: For Normal gastric pH90% CI: [0.7771, 0.9361]
Comparison: For Elevated gastric pH90% CI: [1.376, 1.776]
Comparison: For Elevated gastric pH90% CI: [1.248, 1.604]
Comparison: For Elevated gastric pH90% CI: [0.7972, 1.027]
Primary
Maximum Plasma Concentration (Cmax) of UCB0599 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Maximum Plasma Concentration (Cmax) of UCB0599 in Part B | 502.5 ng/mL | Geometric Coefficient of Variation 29.8 |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Maximum Plasma Concentration (Cmax) of UCB0599 in Part B | 602.9 ng/mL | Geometric Coefficient of Variation 42.4 |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Maximum Plasma Concentration (Cmax) of UCB0599 in Part B | 1757 ng/mL | Geometric Coefficient of Variation 36.4 |
| Part B: UCB0599 360 mg (Japanese Participants) | Maximum Plasma Concentration (Cmax) of UCB0599 in Part B | 483.2 ng/mL | Geometric Coefficient of Variation 42.6 |
| Part B: Pooled Placebo (Chinese Participants) | Maximum Plasma Concentration (Cmax) of UCB0599 in Part B | 737.5 ng/mL | Geometric Coefficient of Variation 35.7 |
| Part B: UCB0599 90 mg (Chinese Participants) | Maximum Plasma Concentration (Cmax) of UCB0599 in Part B | 1525 ng/mL | Geometric Coefficient of Variation 24.8 |
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: 1. Results in death 2. Is life-threatening 3. Required in patient hospitalisation or prolongation of existing hospitalisation 4. Results in persistent disability/incapacity 5. Was a congenital anomaly or birth defect 6. Important medical events
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B | 0 percentage of participants |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B | 0 percentage of participants |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B | 0 percentage of participants |
| Part B: UCB0599 360 mg (Japanese Participants) | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B | 0 percentage of participants |
| Part B: Pooled Placebo (Chinese Participants) | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B | 0 percentage of participants |
| Part B: UCB0599 90 mg (Chinese Participants) | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B | 0 percentage of participants |
| Part B: UCB0599 180 mg (Chinese Participants) | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B | 0 percentage of participants |
| Part B: UCB0599 360 mg (Chinese Participants) | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (Serious TEAEs) in Part B | 0 percentage of participants |
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.
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B | 33.3 percentage of participants |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B | 25.0 percentage of participants |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B | 0 percentage of participants |
| Part B: UCB0599 360 mg (Japanese Participants) | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B | 0 percentage of participants |
| Part B: Pooled Placebo (Chinese Participants) | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B | 33.3 percentage of participants |
| Part B: UCB0599 90 mg (Chinese Participants) | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B | 12.5 percentage of participants |
| Part B: UCB0599 180 mg (Chinese Participants) | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B | 33.3 percentage of participants |
| Part B: UCB0599 360 mg (Chinese Participants) | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part B | 25.0 percentage of participants |
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.
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 15)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B | 0 percentage of participants |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B | 0 percentage of participants |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B | 0 percentage of participants |
| Part B: UCB0599 360 mg (Japanese Participants) | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B | 0 percentage of participants |
| Part B: Pooled Placebo (Chinese Participants) | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B | 0 percentage of participants |
| Part B: UCB0599 90 mg (Chinese Participants) | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B | 0 percentage of participants |
| Part B: UCB0599 180 mg (Chinese Participants) | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B | 0 percentage of participants |
| Part B: UCB0599 360 mg (Chinese Participants) | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part B | 0 percentage of participants |
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: 1. Results in death 2. Is life-threatening 3. Required in patient hospitalisation or prolongation of existing hospitalisation 4. Results in persistent disability/incapacity 5. Was a congenital anomaly or birth defect 6. Important medical events
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (TEAEs) in Part A | 0 percentage of participants |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (TEAEs) in Part A | 0 percentage of participants |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Percentage of Study Participants With Serious Treatment-emergent Adverse Events (TEAEs) in Part A | 0 percentage of participants |
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.
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part A | 38.1 percentage of participants |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part A | 31.0 percentage of participants |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part A | 35.7 percentage of participants |
Secondary
Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part A
Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: UCB0599: Capsule 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part A | 0 percentage of participants |
| Part A: UCB0599: Non-encapsulated Tablet 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part A | 0 percentage of participants |
| Part A: UCB0599: Encapsulated Tablet 180 mg | Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Study in Part A | 0 percentage of participants |