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

NCT03168984 | Completed Phase 1

• 2 other identifiers: UP00392017-000385-30
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Japanese and Caucasian Subjects

Keywords

Healthy Japanese subjects; Healthy Caucasian subjects; UCB0942

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

  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.

Study Arms (2)

UCB0942

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

UCB0942 DRUG

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

UCB0942

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma S.P.R.L.: lead

Study Sites (1)

Up0039 001

London, United Kingdom

Location

Study Officials

• UCB Cares

  +1 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 30, 2017
• Study Start: May 5, 2017
• Primary Completion: August 14, 2017
• Study Completion: August 14, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)