PsoriasisPhase 1NCT02303509
Study to Assess Safety, Tolerability, Pharmacokinetic & Pharmacodynamic Effect of UCB5857 in Healthy & Psoriatic Subject
A Phase 1 study testing UCB5857 Part 1 and UCB5857 Part 2 in people with Psoriasis, run by UCB Pharma at 1 site in United Kingdom.
Trial summary
To evaluate the safety and tolerability of UCB5857. Part 1 of the study explores single doses of the drug. Part 2 of the study explores giving the drug every day for 14 days. The study uses healthy and psoriasis subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- UCB5857 Part 1 and UCB5857 Part 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Feb 2014
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is male or female, aged between 18 and 55 years (inclusive).
- Female subjects must have a negative serum pregnancy test at Screening, and be of nonchildbearing potential, defined as:
- Being postmenopausal (for at least 2 years prior to Screening), verified by serum follicle-stimulating hormone (FSH) level >40 mIU/ mL at Screening, or
- Having undergone complete hysterectomy, bilateral tubal ligation, and/ or bilateral oophorectomy, or
- Being congenital sterile
- Male subject confirms that, during the study period and for a period of 3 months or 5 half lives after the last administration of the IMP (whichever is longer), when having sexual intercourse with a woman of childbearing potential, a method of highly effective contraception will be used (eg, condom + spermicide, and an additional contraceptive method used by the partner). Male contraception is not required if the male subject has undergone effective vasectomy >3 months prior to the study; however, his female partner must use a contraceptive method during the study period and for a period of 3 months or 5 half-lives after the last administration of the IMP (whichever is longer)
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- Subject is of normal weight as determined by a body mass index (BMI) of between 18.0 and 30.0 kg/ m2 (inclusive), with a body weight of at least 50 kg (for healthy subjects only)
- Subject is in good physical and mental health, in the opinion of the Investigator, determined on the basis of medical history and general clinical examination at Screening
- Subject has clinical laboratory test results within the reference ranges of the testing laboratory. Subjects with isolated test results that are outside the specified ranges and that are deemed as clinically nonsignificant will be allowed at the discretion of the Investigator, following discussion with the Sponsor's Study Physician, excluding ALT, AST, alkaline phosphate and bilirubin, which have to be within normal range. If a subject has 1 isolated test result outside the specific range that is deemed clinically significant, rescreening may be allowed at the discretion of the Investigator, following discussion with the Sponsor's Study Physician
- Subject has BP and pulse rate within normal range in a supine position after 5 minutes rest (systolic BP: 90 to 140 mmHg, diastolic BP: 50 to 90 mmHg, pulse rate: 40 to 90 bpm). Results that are outside the specified ranges and that are deemed as clinically nonsignificant will be allowed at the discretion of the Investigator, following discussion with the Sponsor's Study Physician. If a subject has 1 isolated finding outside the specific range which is deemed clinically significant, rescreening may be allowed at the discretion of the Investigator, following discussion with the Sponsor's Study Physician
- Subject has a body temperature (oral or tympanic) between 35.0 and 37.5°C (95 and 99.5°F) inclusive
- Subject's ECG is considered "normal" or "abnormal" but clinically nonsignificant (as interpreted by the Investigator). If the subject has 1 isolated finding outside the specific range that is deemed potentially clinically significant, rescreening may be allowed at the discretion of the Investigator, following discussion with the Sponsor's Study Physician
- In addition for the psoriatic subjects cohort
- Subject has a BMI at Screening <35 kg/ m2
- Subject has a confirmed diagnosis of mild-to-moderate plaque-type psoriasis for at least 6 months involving ≤10% of BSA (excluding the scalp)
- Subject has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsies
Who cannot join
- Subjects are not permitted to enroll in the study if any of the following criteria is met:
- Healthy and psoriatic subjects
- Subject is an employee or direct relative of an employee of PAREXEL or the Sponsor
- Subject has participated in another study of an investigational medication (or a medical device) within the last 3 months or 5 half-lives of the study medication, whichever is longer, or is currently participating in another study of an investigational medication (or a medical device)
- Subject has made a blood donation (>400mL) or had a comparable blood loss (>350 mL) within the 3 months prior to first intake of study drug
- Subject tests positive for human immunodeficiency virus-1/2 antibody (HIV-1/2Ab), hepatitis B surface antigen, or hepatitis C virus antibody.
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- Subject is not willing to avoid heavy physical exertion for 2 days before drug administration and during the study
- Subject has a history of alcohol and/or drug abuse up to 6 months before Screening
- Subject has an alcohol consumption of more than 21 units (males) or 14 units (females) of alcohol per week (1 unit of alcohol is equivalent to 10 mL ethanol; for example, 330 mL of 5 % alcohol by volume beer =1.7 units; 125 mL of 12 % wine =1.5 units: 50 mL of spirits with 40 % of alcohol by volume =2 units)
- Subject tests positive for alcohol and/or drugs (urine tests) at Screening or Day -1
- Subject has received any prescription (including hormonal replacement therapy) or nonprescription medicines, including over-the-counter (OTC) remedies, herbal, and dietary supplements (other than vitamins within recommended daily dose limits), within 21 days or 5 half-lives of the respective drug, whichever is longer, prior to Check-in (Day -1), other than occasional use of analgesics such as paracetamol (acetaminophen), ibuprofen, or intranasal corticosteroids for seasonal rhinitis
- Subject has consumed any grapefruit, grapefruit juice, or grapefruit-containing products, as well as St John's Wort-containing products, within 14 days prior to Check-in (Day -1)
- Subject has a known hypersensitivity to any components of the IMP
- Subject has current or past history of GI ulceration
- Subject is considered anti-immunoglobulin E (IgE) nonresponsive if CD63 induction on basophils is <10 %.
- Subject has cardiovascular or cerebrovascular disease, including hypertension, angina, ischemic heart disease, transient ischemic attacks, stroke, and peripheral arterial disease sufficient to cause symptoms and/ or require therapy to maintain stable status
- Subject has diabetes mellitus of any type requiring insulin
- Subject has unstable/poorly controlled Type 2 diabetes mellitus, defined as glycosylated hemoglobin type A1c (HbA1c) level ≥8.5 % or glucose intolerant
- Subject
- Has an active infection (eg, sepsis, pneumonia, abscess)
- Has history of latent, chronic, or recurrent infections (eg, tuberculosis, recurrent sinusitis, genital herpes, urinary tract infections) or at risk of infection (surgery, trauma, infection requiring antibiotics, history of skin abscesses) within 3 months prior to IMP administration
- Has experienced a significant episode of gastroenteritis (defined as loose stools associated with abdominal pain and/ or fever) during the 7 days prior to IMP administration
- When in doubt, the Investigator should confer with the Sponsor's Study Physician
- Subject has a history of positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening (interferon gamma release assay [IGRA] testing)
- Subject has received live attenuated vaccination within 3 months or any other type of vaccine within 4 weeks prior to Screening or intends to have such a vaccination during the course of the study
- Subject who has any of the following hematology values at Screening:
- Hemoglobin; for women <11 g/ dL; for men <13 g/ dL
- ANC <1.5x109/ L (<1500/ μL)
- Subject has an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risks associated with participating in the study. In addition any subject with any of the following findings will be excluded:
- QTcF interval >450 ms in 2 of 3 ECGs.
- Bundle branch blocks and other conduction abnormalities (other than mild first degree atrioventricular block) such that PR interval ≥220 ms
- Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats
- In the judgment of the Investigator, T-wave configurations are not of sufficient quality for assessing QT interval duration
- Subject has active neoplastic disease or history of neoplastic disease within 5 years of Screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)
- Subject has any other acute or chronic illness which, in the opinion of the Investigator or the Sponsor's Study Physician, could pose a threat or harm to the subject
- Subject is legally institutionalized or has a mental health condition or related care provision (eg, guardianship) that would impede the subject from providing voluntary informed consent to participate in the study
- Healthy subjects only
- The subject has used nicotine-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, nicotine patch, or nicotine gum) within 6 weeks prior to Check-in (Day -1) or anticipates an inability to abstain from these products for the duration of the study
- Subject has a high consumption of xanthine-containing products (≥300 mg of xanthine equivalent per day [1 cup of coffee ≈ 100 mg of caffeine; 1 cup of tea ≈ 30 mg of caffeine; 1 glass of cola ≈ 20 mg of caffeine]) Psoriatic subjects only
- Subject has received systemic nonbiologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening.
- Subject has received treatment with biologic agents within 12 months prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study Evaluating The Safety/Tolerability, Pharmacokinetic and Pharmacodynamic Effects of UCB5857 in Healthy and Mild-to-Moderate Psoriatic Subjects
To evaluate the safety and tolerability of UCB5857. Part 1 of the study explores single doses of the drug. Part 2 of the study explores giving the drug every day for 14 days. The study uses healthy and psoriasis subjects.
Read the detailed description
This is a first-in-human (FIH), Phase 1, randomized, double-blind, placebo controlled, single center study designed to evaluate the safety/ tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of UCB5857 following oral administration of single ascending doses (SAD) in healthy subjects (Part 1) and multiple ascending doses (MAD) in healthy and mild-to-moderate psoriatic subjects (Part 2).
The primary objective of this study is to investigate the safety and tolerability of UCB5857 when given as single oral doses in healthy subjects and as ascending multiple oral doses in healthy subjects and mild-to-moderate psoriatic subjects.
- Conditions
- Psoriasis
- Being tested
- UCB5857 Part 1, UCB5857 Part 2, Placebo
- Keywords
- Healthy Subjects, Mild to moderate Psoriasis, Subjects
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCB5857 Part 1Drug
Active substance: UCB5857
Pharmaceutical form: Capsule
Concentration: 1 mg, 5 mg, 10 mg or 15 mg
Route of administration: Oral
UCB5857 Part 2Drug
Active substance: UCB5857
Pharmaceutical form: Capsule
Concentration: 5 mg, 8 mg, 15 mg
Route of administration: Oral
PlaceboOther
Active substance: Placebo
Pharmaceutical form: Capsule
Concentration: Avicel PH 102, 50 mg
Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| UCB5857 Part 1 | Experimental | Part 1: Subjects assigned to UCB5857 or placebo single dose. Receives: Drug: UCB5857 Part 1; Other: Placebo |
| UCB5857 Part 2 | Experimental | Part 2: Subjects assigned to UCB5857 or placebo multiple doses. Receives: Drug: UCB5857 Part 2; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events during the study
Measured: Day -1 to single dose Day 4 (Part 1) and Day -1 to multiple dose Day 18 (Part 2)
Secondary outcomes (27)
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t))
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC(0-24))
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The area under the plasma concentration-time curve from time 0 to infinity (AUC)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The maximum observed plasma concentration of UCB5857 after single dosing, obtained directly from the observed plasma concentration-time curves (Cmax)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The time of occurrence of Cmax, obtained directly from the observed plasma concentration-time curves (tmax)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The apparent terminal half-life (t1/2)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The terminal elimination rate constant in plasma (λz)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The apparent volume of distribution after single dosing (Vz/F)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The apparent total body clearance after single dosing (CL/F)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
Mean residence time (MRT)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t))
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC(0-24))
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The time of occurrence of Cmax, obtained directly from the observed plasma concentration-time curves (tmax)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The apparent terminal half-life (t1/2)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The terminal elimination rate constant in plasma (λz)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Mean residence time (MRT)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The maximum observed plasma concentration of UCB5857 during steady state, obtained directly from the observed plasma concentration-time curves (Cmaxss)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The minimum observed plasma concentration of UCB5857 during steady state immediately before the next dose would be administered, obtained directly from the observed plasma concentration-time curves (Ctrough)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The apparent volume of distribution at steady state (Vzss/F)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The apparent total body clearance at steady state (CLss/F)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Accumulation factor based on AUC(0-24) (RAUC)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Accumulation factor based on Cmax (R(Cmax))
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Time independency factor (TI)
Measured: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Total amount of drug excreted in urine from time 0 to time t (Ae(0-t))
Measured: Urine pharmacokinetic samples will be taken predose and 0 - 5 hours, 5 - 10 hours, 10 - 24 hours, 24 - 48 hours, 48 - 72 hours postdose on Day 1 (Part 1 and Part 2) and on Day 14 (Part 2)
Renal clearance (CLr)
Measured: Urine pharmacokinetic samples will be taken predose and 0 - 5 hours, 5 - 10 hours, 10 - 24 hours, 24 - 48 hours, 48 - 72 hours postdose on Day 1 (Part 1 and Part 2) and on Day 14 (Part 2)
Fraction of drug excreted in urine (Fe)
Measured: Urine pharmacokinetic samples will be taken predose and 0 - 5 hours, 5 - 10 hours, 10 - 24 hours, 24 - 48 hours, 48 - 72 hours postdose on Day 1 (Part 1 and Part 2) and on Day 14 (Part 2)
Basophil degranulation
Measured: Samples will be taken predose, 0.5, 1, 2, 4, 6, 8, 10, 24 hours postdose on Day 1 (Part 1 and Part 2) and predose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 hours postdose on Day 14 (Part 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startAug 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- UCB, Cares, Study director, 1-877-822-9493
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303509
- Sponsor's protocol ID
- PS0001
- Other IDs
- 2013-002323-42
- Status last verified
- Nov 2014
- First submitted
- 25 Nov 2014
- Last updated
- 1 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study Evaluating The Safety/Tolerability, Pharmacokinetic and Pharmacodynamic Effects of UCB5857 in Healthy and Mild-to-Moderate Psoriatic Subjects
- ClinicalTrials.gov ID
- NCT02303509
- Acronym / sponsor ID
- PS0001
- Conditions
- Psoriasis
- Keywords
- Healthy Subjects, Mild to moderate Psoriasis, Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 Dec 2014 (estimated)
- 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.
To evaluate the safety and tolerability of UCB5857. Part 1 of the study explores single doses of the drug. Part 2 of the study explores giving the drug every day for 14 days. The study uses healthy and psoriasis subjects.
Detailed description
This is a first-in-human (FIH), Phase 1, randomized, double-blind, placebo controlled, single center study designed to evaluate the safety/ tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of UCB5857 following oral administration of single ascending doses (SAD) in healthy subjects (Part 1) and multiple ascending doses (MAD) in healthy and mild-to-moderate psoriatic subjects (Part 2).
The primary objective of this study is to investigate the safety and tolerability of UCB5857 when given as single oral doses in healthy subjects and as ascending multiple oral doses in healthy subjects and mild-to-moderate psoriatic subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCB5857 Part 1 | Experimental | Drug: UCB5857 Part 1, Other: PlaceboPart 1: Subjects assigned to UCB5857 or placebo single dose. |
| UCB5857 Part 2 | Experimental | Drug: UCB5857 Part 2, Other: PlaceboPart 2: Subjects assigned to UCB5857 or placebo multiple doses. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Subject is male or female, aged between 18 and 55 years (inclusive).
- Female subjects must have a negative serum pregnancy test at Screening, and be of nonchildbearing potential, defined as:
- Male subject confirms that, during the study period and for a period of 3 months or 5 half lives after the last administration of the IMP (whichever is longer), when having sexual intercourse with a woman of childbearing potential, a method of highly effective contraception will be used (eg, condom + spermicide, and an additional contraceptive method used by the partner). Male contraception is not required if the male subject has undergone effective vasectomy >3 months prior to the study; however, his female partner must use a contraceptive method during the study period and for a period of 3 months or 5 half-lives after the last administration of the IMP (whichever is longer)
- Subject is of normal weight as determined by a body mass index (BMI) of between 18.0 and 30.0 kg/ m2 (inclusive), with a body weight of at least 50 kg (for healthy subjects only)
- Subject is in good physical and mental health, in the opinion of the Investigator, determined on the basis of medical history and general clinical examination at Screening
Key exclusion criteria (41 listed)
- Subjects are not permitted to enroll in the study if any of the following criteria is met:
- Healthy and psoriatic subjects
- Subject is an employee or direct relative of an employee of PAREXEL or the Sponsor
- Subject has participated in another study of an investigational medication (or a medical device) within the last 3 months or 5 half-lives of the study medication, whichever is longer, or is currently participating in another study of an investigational medication (or a medical device)
- Subject has made a blood donation (>400mL) or had a comparable blood loss (>350 mL) within the 3 months prior to first intake of study drug
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 |
|---|---|---|
| UCB5857 Part 1Active substance: UCB5857 Pharmaceutical form: Capsule Concentration: 1 mg, 5 mg, 10 mg or 15 mg Route of administration: Oral | Drug | UCB5857 Part 1 |
| UCB5857 Part 2Active substance: UCB5857 Pharmaceutical form: Capsule Concentration: 5 mg, 8 mg, 15 mg Route of administration: Oral | Drug | UCB5857 Part 2 |
| PlaceboActive substance: Placebo Pharmaceutical form: Capsule Concentration: Avicel PH 102, 50 mg Route of administration: Oral | Other | UCB5857 Part 1, UCB5857 Part 2 |
Primary outcome
Incidence of adverse events during the study
Time frame: Day -1 to single dose Day 4 (Part 1) and Day -1 to multiple dose Day 18 (Part 2)
27 secondary outcomes
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t))
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC(0-24))
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The area under the plasma concentration-time curve from time 0 to infinity (AUC)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The maximum observed plasma concentration of UCB5857 after single dosing, obtained directly from the observed plasma concentration-time curves (Cmax)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The time of occurrence of Cmax, obtained directly from the observed plasma concentration-time curves (tmax)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The apparent terminal half-life (t1/2)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The terminal elimination rate constant in plasma (λz)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The apparent volume of distribution after single dosing (Vz/F)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
The apparent total body clearance after single dosing (CL/F)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
Mean residence time (MRT)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 1 (Part 1 and Part 2)
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-t))
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC(0-24))
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The time of occurrence of Cmax, obtained directly from the observed plasma concentration-time curves (tmax)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The apparent terminal half-life (t1/2)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The terminal elimination rate constant in plasma (λz)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Mean residence time (MRT)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The maximum observed plasma concentration of UCB5857 during steady state, obtained directly from the observed plasma concentration-time curves (Cmaxss)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The minimum observed plasma concentration of UCB5857 during steady state immediately before the next dose would be administered, obtained directly from the observed plasma concentration-time curves (Ctrough)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The apparent volume of distribution at steady state (Vzss/F)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
The apparent total body clearance at steady state (CLss/F)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Accumulation factor based on AUC(0-24) (RAUC)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Accumulation factor based on Cmax (R(Cmax))
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Time independency factor (TI)
Time frame: Pharmacokinetic samples will be taken predose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48 and 72 hours postdose on Day 14 (Part 2)
Total amount of drug excreted in urine from time 0 to time t (Ae(0-t))
Time frame: Urine pharmacokinetic samples will be taken predose and 0 - 5 hours, 5 - 10 hours, 10 - 24 hours, 24 - 48 hours, 48 - 72 hours postdose on Day 1 (Part 1 and Part 2) and on Day 14 (Part 2)
Renal clearance (CLr)
Time frame: Urine pharmacokinetic samples will be taken predose and 0 - 5 hours, 5 - 10 hours, 10 - 24 hours, 24 - 48 hours, 48 - 72 hours postdose on Day 1 (Part 1 and Part 2) and on Day 14 (Part 2)
Fraction of drug excreted in urine (Fe)
Time frame: Urine pharmacokinetic samples will be taken predose and 0 - 5 hours, 5 - 10 hours, 10 - 24 hours, 24 - 48 hours, 48 - 72 hours postdose on Day 1 (Part 1 and Part 2) and on Day 14 (Part 2)
Basophil degranulation
Time frame: Samples will be taken predose, 0.5, 1, 2, 4, 6, 8, 10, 24 hours postdose on Day 1 (Part 1 and Part 2) and predose, 0.5, 1, 2, 4, 6, 8, 10, 24, 48 hours postdose on Day 14 (Part 2)
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 1 Dec 2014.
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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
1-877-822-9493
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 UCB5857 Part 1 and UCB5857 Part 2 in people with Psoriasis, run by UCB Pharma 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 16 inclusion and 41 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 1 Dec 2014. 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. 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?
Incidence of adverse events during the study (time frame: Day -1 to single dose Day 4 (Part 1) and Day -1 to multiple dose Day 18 (Part 2)). 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 1 Dec 2014.