Trial Details

Not Recruiting
Basic Information
Clinical ID c2909
Identifier EUCTR2016-003073-18-GB
Trial Title A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686)
Trial URL Visit Original Page
Study Information
Study Results

Yes
Conditions 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 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_ _ MedDRA version: 19.0_ Level: LLT_ Classification code 10013099_ Term: Disease Crohns_ System Organ Class: 100000004856_ ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Interventions Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration Pharmaceutical Form: Oral solution INN or Proposed INN: Ozanimod hydrochloride CAS Number: 1618636-37-5 Current Sponsor code: RPC1063HCL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.1-
Participant Information
Sponsor Celgene International II S鈭氣€爎l
City -
Country/Region United Kingdom
Enrollment Criteria
Sex Requirement NOT SPECIFIED
Age Requirement -
Study Design
Study Type Interventional clinical trial of medicinal product
Phase PHASE1
Time Information
Start Date 2025-04-24
Primary Completion Date 2017-12-07
Completion Date 2016-11-21