Clinical trial NCT03168984: A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB0942 in Healthy Japanese and Caucasian Subjects
Official title: A Single-Centre, Investigator/Subject Blind, Placebo-Controlled, Single and Multiple Oral Dose Investigation of Safety, Tolerability, and Pharmacokinetics of UCB0942 in Healthy Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Japanese and Caucasian Subjects
Keywords: Healthy Japanese subjects
Healthy Caucasian subjects
UCB0942
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of UCB0942 in Japanese and Caucasian subjects.


Eligibility criteria: 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 exclusion criteria may apply

Primary outcomes:
measure: Cmax: maximum observed plasma concentration of UCB0942 and metabolites
timeFrame: 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.
measure: AUC(0-t): area under the plasma concentration-time curve from time zero to the time of last detectable concentration for UCB0942 and metabolites
timeFrame: 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 outcomes:
measure: tmax: time of maximum concentration of UCB0942 and metabolites during the Single-dose period
timeFrame: 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.
measure: tmax: time of maximum concentration of UCB0942 and metabolites during the Multiple-dose period
timeFrame: 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.
measure: AUC: area under the plasma concentration-time curve from time zero to infinity for UCB0942 and metabolites during the Single-dose period
timeFrame: 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.
measure: t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Single-dose period
timeFrame: 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.
measure: t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Multiple-dose period
timeFrame: 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.
measure: RCmax: Accumulation ratio of Cmax for UCB0942 and metabolites during the Multiple-dose period
timeFrame: 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.
measure: AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Single-dose period
timeFrame: 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.
measure: AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Multiple-dose period
timeFrame: 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.
measure: RAUC: Accumulation ratio of AUCtau for UCB0942 and metabolites during the Multiple-dose period
timeFrame: 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.
measure: Adverse events (AEs) reported spontaneously by the subject or observed by the investigator
timeFrame: From Screening until safety follow up visit (up to Week 18)
measure: Change from baseline in laboratory variables, vital sign variables, 12-lead ECG variables and physical examination
timeFrame: From Baseline until safety follow up visit (up to Week 18)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Up0039 001
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: