A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body

Phase 1

• Conditions: MedDRA version: 19.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD).; MedDRA version: 19.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders; MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

• Registration Number: EUCTR2016-003073-18-GB
• Lead Sponsor: Celgene International II Sàrl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-16
• Study Completion: 2016-11-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1.Subject is male
2.Subject is 30 to 65 years of age
3.Subject has a body weight of at least 50 kg; body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
4.Subject is willing and able to communicate and participate in the whole study
5.Subject has regular bowel movements (average stool production =1 and =3 stools per day)
6.Subject has suitable veins for multiple cannulation as assessed by the investigator at screening
7.Subject is able to comprehend the informed consent form, provide written informed consent, and able to comply with requirements of the study.
8.Subject agrees to use an adequate method of contraception

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1.Subject has received any IMP in a clinical research study within the previous 3 months
2.Subject is a study site employee or an immediate family member of a study site or sponsor employee
3.Subject has a history of any drug or alcohol abuse in the past 2 years
4.Subject has regular alcohol consumption of >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
5.Subject is a current smoker or has smoked within the last 12 months; including cigarettes, e-cigarettes and nicotine replacement products. Positive cotinine test result at screening and each admission
6.Subject has radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
7.Subjects has been enrolled in an ADME study in the last 12 months
8.Subject has clinically significant abnormal biochemistry or haematology as judged by the investigator
9.Subject has positive drugs of abuse test result
10.Subject has positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
11.Subject has evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <90 mL/min using the Cockcroft-Gault equation
12.Subject has ALT or AST concentration >1.25 × the upper limit of normal at screening
13.Subject has history of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
14.Subject has had serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
15.Subject has presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
16.Subject has donated or lost greater than 400 mL of blood within the previous 3 months
17.Subject is taking, or has taken, any prescribed or over-the-counter drug (other than 2 g per 24 h paracetamol) dietary or herbal remedies within 14 days before IMP administration, or has taken St. John’s wort within 28 days before IMP administration. Exceptions may apply on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor’s medical monitor.
18.Subject fails to satisfy the investigator of fitness to participate for any other reason

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified