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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2017-08-14

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Japanese and Caucasian Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

UCB0942

Intervention Type DRUG

* Pharmaceutical form: Film-coated tablet
* Route of administration: Oral use

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

* Pharmaceutical form: Film-coated tablet
* Route of administration: Oral use

Interventions

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UCB0942

* Pharmaceutical form: Film-coated tablet
* Route of administration: Oral use

Intervention Type DRUG

Placebo

* Pharmaceutical form: Film-coated tablet
* Route of administration: Oral use

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes