Healthy Japanese and Caucasian Subjects
Conditions
Keywords
Healthy Japanese subjects, Healthy Caucasian subjects, UCB0942
Brief summary
The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of UCB0942 in Japanese and Caucasian subjects.
Interventions
DRUGUCB0942
* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use
OTHERPlacebo
* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use
Sponsors
UCB Biopharma S.P.R.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject is male or female and between 20 and 55 years of age (inclusive) * Subject is in good physical and mental health * Female subjects will use an efficient form of contraception for the duration of the study (unless menopausal) * Male subject agrees that, during the study period, when having sexual intercourse with a woman of childbearing potential, he will use an efficient barrier contraceptive AND that the respective partner will use an additional efficient contraceptive method * For Japanese subjects: Subject is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has all 4 Japanese grandparents born in Japan) * For Caucasians: Subject is of Caucasian descent as evidenced by appearance and verbal confirmation of familial heritage (a subject has 4 Caucasian grandparents).
Exclusion criteria
At screening: * Previous study participation with another investigational medicinal product (IMP) within 3 months * History of alcohol/drug abuse * History of psychiatric condition and suicide attempt * Any medical condition unfit for study (including history of cancer) * History of hypersensitivity for IMP components * Taking concomitant medications * Positive for human immunodeficiency virus (HIV)/ hepatitis B virus (HBV)/ hepatitis C virus (HCV) * Abnormal liver function tests (LFTs), abnormal safety bloods/ vitals/ physical examination and electrocardiogram (ECG) findings * Positive for pregnancy test * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax: maximum observed plasma concentration of UCB0942 and metabolites | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. |
| AUC(0-t): area under the plasma concentration-time curve from time zero to the time of last detectable concentration for UCB0942 and metabolites | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC: area under the plasma concentration-time curve from time zero to infinity for UCB0942 and metabolites during the Single-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | AUC is calculated as AUC(0-t)+Clast/kel, where Clast is the last observed quantifiable plasma concentration and kel is the apparent terminal elimination rate constant |
| t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Single-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | — |
| t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | — |
| RCmax: Accumulation ratio of Cmax for UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | — |
| tmax: time of maximum concentration of UCB0942 and metabolites during the Single-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | — |
| AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | — |
| RAUC: Accumulation ratio of AUCtau for UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | — |
| Adverse events (AEs) reported spontaneously by the subject or observed by the investigator | From Screening until safety follow up visit (up to Week 18) | — |
| Change from baseline in laboratory variables, vital sign variables, 12-lead ECG variables and physical examination | From Baseline until safety follow up visit (up to Week 18) | — |
| AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Single-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | — |
| tmax: time of maximum concentration of UCB0942 and metabolites during the Multiple-dose period | Plasma will be collected predose and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours postdose. | — |
Countries
United Kingdom
Outcome results
None listed