Clinical trial NCT05845645: A Study to Test Bioavailability of of 2 New Formulations of UCB0599 in Healthy Participants in Part A and to Test Safety, Tolerability, and Pharamacokinetic (PK) of UCB0599 in Healthy Japanese and Chinese Participants in Part B
Official title: A 2-Part Study to Evaluate the Relative Bioavailability of 2 New Formulations of UCB0599 and the Effect of Esomeprazole on the PK of UCB0599 in Healthy Participants (Part A, Open-Label) and to Assess the Safety/Tolerability and PK of UCB0599 in Healthy Participants of Japanese and Chinese Origins (Part B, Double-Blind)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Study Participants
Keywords: Phase 1
Healthy Study Participants
UCB0599
Bioavailability study
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of UCB0599 in Part A
timeFrame: Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of UCB0599 in Part A
timeFrame: Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)
measure: Area under the plasma concentration-time curve from time 0 to infinity (AUC(inf)) of UCB0599 in Part A
timeFrame: Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)
measure: Percentage of study participants with treatment-emergent adverse events (TEAEs) in Part B
timeFrame: From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 17)
measure: Percentage of study participants with serious treatment-emergent adverse events (serious TEAEs) in Part B
timeFrame: From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 17)
measure: Percentage of study participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from study in Part B
timeFrame: From Baseline (Day 1) to Safety Follow-up Period of Part B (up to Day 17)
measure: Maximum plasma concentration (Cmax) of UCB0599 in Part B
timeFrame: Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t)) of UCB0599 in Part B
timeFrame: Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)
measure: Area under the plasma concentration-time curve from time 0 to infinity (AUC(inf)) of UCB0599 in Part B
timeFrame: Plasma samples will be collected from Baseline (Day 1) predose at predefined time points (up to Day 4)
Secondary outcomes:
measure: Percentage of study participants with treatment-emergent adverse events (TEAEs) in Part A
timeFrame: From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)
measure: Percentage of study participants with serious treatment-emergent adverse events (TEAEs) in Part A
timeFrame: From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)
measure: Percentage of study participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from study in Part A
timeFrame: From Baseline (Day 1) to Safety Follow-up Period of Part A (up to Day 39)
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Up0073 10001
state: California
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: