Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03168984
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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

Condition or disease Intervention/treatment Phase
Healthy Japanese and Caucasian Subjects Drug: UCB0942 Other: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Actual Study Start Date : May 5, 2017
Actual Primary Completion Date : August 14, 2017
Actual Study Completion Date : August 14, 2017

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




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168984


Locations
Layout table for location information
United Kingdom
Up0039 001
London, United Kingdom
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Investigators
Layout table for investigator information
Study Director: UCB Cares +1 844 599 2273 (UCB)

Layout table for additonal information
Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT03168984     History of Changes
Other Study ID Numbers: UP0039
2017-000385-30 ( EudraCT Number )
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Healthy Japanese subjects
Healthy Caucasian subjects
UCB0942