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Completed

NCT Number: NCT03168984

A Study to Investigate the 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.

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Key information

Conditions

Healthy Japanese and Caucasian Subjects

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Up0039 001

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UCB0942

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

Placebo

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

Primary outcomes

  1. Cmax: maximum observed plasma concentration of UCB0942 and metabolites

    Time frame: 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.

  2. AUC(0-t): area under the plasma concentration-time curve from time zero to the time of last detectable concentration for UCB0942 and metabolites

    Time frame: 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

  1. tmax: time of maximum concentration of UCB0942 and metabolites during the Single-dose period

    Time frame: 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.

  2. tmax: time of maximum concentration of UCB0942 and metabolites during the Multiple-dose period

    Time frame: 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.

  3. AUC: area under the plasma concentration-time curve from time zero to infinity for UCB0942 and metabolites during the Single-dose period

    Time frame: 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

  4. t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Single-dose period

    Time frame: 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.

  5. t1/2: apparent terminal elimination half-life of UCB0942 and metabolites during the Multiple-dose period

    Time frame: 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.

  6. RCmax: Accumulation ratio of Cmax for UCB0942 and metabolites during the Multiple-dose period

    Time frame: 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.

  7. AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Single-dose period

    Time frame: 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.

  8. AUCtau: area under the curve over a dosing interval (12hrs) for UCB0942 and metabolites during the Multiple-dose period

    Time frame: 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.

  9. RAUC: Accumulation ratio of AUCtau for UCB0942 and metabolites during the Multiple-dose period

    Time frame: 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.

  10. Adverse events (AEs) reported spontaneously by the subject or observed by the investigator

    Time frame: From Screening until safety follow up visit (up to Week 18)

  11. Change from baseline in laboratory variables, vital sign variables, 12-lead ECG variables and physical examination

    Time frame: From Baseline until safety follow up visit (up to Week 18)

Sponsors and collaborators

Lead sponsor

UCB Biopharma S.P.R.L.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 30, 2017
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.