Study to Assess Safety, Tolerability, Pharmacokinetic & Pharmacodynamic Effect of UCB5857 in Healthy & Psoriatic Subject

NCT02303509 | Completed Phase 1

• 2 other identifiers: PS00012013-002323-42
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Keywords

Healthy Subjects; Mild to moderate Psoriasis; Subjects

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events during the study

  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))

  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))

  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)

  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)

  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)

  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)

Study Arms (2)

UCB5857 Part 1

EXPERIMENTAL

Part 1: Subjects assigned to UCB5857 or placebo single dose.

Drug: UCB5857 Part 1; Other: Placebo

UCB5857 Part 2

EXPERIMENTAL

Part 2: Subjects assigned to UCB5857 or placebo multiple doses.

Drug: UCB5857 Part 2; Other: Placebo

Interventions

UCB5857 Part 1 DRUG

Active substance: UCB5857 Pharmaceutical form: Capsule Concentration: 1 mg, 5 mg, 10 mg or 15 mg Route of administration: Oral

UCB5857 Part 1

UCB5857 Part 2 DRUG

Active substance: UCB5857 Pharmaceutical form: Capsule Concentration: 5 mg, 8 mg, 15 mg Route of administration: Oral

UCB5857 Part 2

Placebo OTHER

Active substance: Placebo Pharmaceutical form: Capsule Concentration: Avicel PH 102, 50 mg Route of administration: Oral

UCB5857 Part 1; UCB5857 Part 2

Eligibility Criteria

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

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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.
• 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 %.

Sponsors & Collaborators

• UCB Pharma: lead
• Parexel: collaborator

Study Sites (1)

001

Harrow, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• UCB, Cares

  1-877-822-9493

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 1, 2014
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: December 1, 2014

Record last verified: 2014-11

Locations

GB (1)