A Study to Test Bioavailability of of 2 New Formulations of UCB0599 in Healthy Participants in Part A and to Test Safety, Tolerability, and Pharmacokinetic (PK) of UCB0599 in Healthy Japanese and Chinese Participants in Part B

UCB Biopharma SRL73 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Study Participants

Interventions

UCB0599DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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)

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)

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)

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

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

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

Secondary Outcomes

Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs) in Part A

Time frame: 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

Time frame: 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

Time frame: From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)

A Study to Test Bioavailability of of 2 New Formulations of UCB0599 in Healthy Participants in Part A and to Test Safety, Tolerability, and Pharmacokinetic (PK) of UCB0599 in Healthy Japanese and Chinese Participants in Part B

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes