Healthy Japanese and Caucasian SubjectsPhase 1NCT03168984
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB0942 in Healthy Japanese and Caucasian Subjects
A Phase 1 study testing UCB0942 in people with Healthy Japanese and Caucasian Subjects, run by UCB Biopharma S.P.R.L. at 1 site in United Kingdom.
Trial summary
The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of UCB0942 in Japanese and Caucasian subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Japanese and Caucasian Subjects
- What is being tested?
- UCB0942
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 May 2017to 14 Aug 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- UCB0942, Placebo
- Keywords
- Healthy Japanese subjects, Healthy Caucasian subjects, UCB0942
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB0942Drug
- Pharmaceutical form: Film-coated tablet
- Route of administration: Oral use
PlaceboOther
- Pharmaceutical form: Film-coated tablet
- Route of administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: maximum observed plasma concentration of UCB0942 and metabolites
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From Baseline until safety follow up visit (up to Week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start5 May 2017
- Primary completion14 Aug 2017
- Study completion14 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Japanese and Caucasian SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma S.P.R.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168984
- Sponsor's protocol ID
- UP0039
- Other IDs
- 2017-000385-30, 2017
- Status last verified
- Aug 2017
- First submitted
- 17 May 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03168984
- Acronym / sponsor ID
- UP0039
- Conditions
- Healthy Japanese and Caucasian Subjects
- Keywords
- Healthy Japanese subjects, Healthy Caucasian subjects, UCB0942
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- UCB Biopharma S.P.R.L.Industry (pharma, biotech, devices)
- Study start
- 5 May 2017 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 14 Aug 2017 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of UCB0942 in Japanese and Caucasian subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCB0942 | Experimental | Drug: UCB0942Cohort 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) |
| Placebo | Placebo comparator | Other: PlaceboCohort 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 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UCB0942* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use | Drug | UCB0942 |
| Placebo* Pharmaceutical form: Film-coated tablet * Route of administration: Oral use | Other | Placebo |
Primary outcome
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.
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.
11 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
+1 844 599 2273 (UCB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UCB0942 in people with Healthy Japanese and Caucasian Subjects, run by UCB Biopharma S.P.R.L. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.