A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB0942 in Healthy Japanese and Caucasian Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Japanese and Caucasian Subjects
• Intervention / Treatment: Drug: UCB0942; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Up0039 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UCB0942; Cohort 1 (Japanese subjects): Single dose of UCB0942 (dosage regimen 1) Cohort 2 (Japanese subjects): Single dose of UCB0942 (dosage regimen 2) Cohort 3 (Japanese subjects): Single dose of UCB0942 (dosage regimen 3) followed, after maximum 21 days, by multiple doses of UCB0942 (dosage regimen 2) Cohort 4 (Caucasian subjects): Single dose of UCB0942 (dosage regimen 3) followed, after maximum 21 days, by multiple doses of UCB0942 (dosage regimen 2)	Drug: UCB0942; Pharmaceutical form: Film-coated tablet; Route of administration: Oral use
Placebo Comparator: Placebo; Cohort 1 and Cohort 2: Single dose of Placebo Cohort 3 and Cohort 4: Single dose of Placebo followed, after maximum 21 days, by multiple doses of Placebo	Other: Placebo; Pharmaceutical form: Film-coated tablet; Route of administration: Oral use

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
AUC: area under the plasma concentration-time curve from time zero to infinity for UCB0942 and metabolites during the Single-dose period	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	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 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.
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.
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)

Collaborators and Investigators

• Sponsor: UCB Biopharma S.P.R.L.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2017
• Primary Completion (Actual): August 14, 2017
• Study Completion (Actual): August 14, 2017

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2017
• Last Update Submitted That Met QC Criteria: August 17, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Healthy Japanese subjects; UCB0942; Healthy Caucasian subjects
• Other Study ID Numbers: UP0039; 2017-000385-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No