A Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults

NCT02994381 | Completed Phase 1

• 1 other identifier: RPC01-1909
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This will be an open-label, non-randomized, single oral dose study in healthy male subjects. All subjects will receive a single oral dose of 10 mL of \[14C\]-RPC1063 Solution (0.1 mg/mL), containing NMT 1.3 MBq (37 μCi) 14C.

Conditions

Healthy Volunteers

Keywords

Healthy Male Adults; 14C; RPC1063

Outcome Measures

Primary Outcomes (2)

• Percentage of elimination of [14C]-RPC1063

  Total recovery of radioactivity in urine and feces expressed as a percentage of total radioactive dose in each 24 h interval and cumulatively

  Up to 4 weeks

• Pharmacokinetic- amount of drug excreted

  Cumulative amount of drug excreted unchanged in the drug in urine

  Up to 4 weeks

Secondary Outcomes (10)

• Pharmacokinetic- Cmax

  Up to 8 days

• Pharmacokinetic- Tmax

  Up to 8 days

• Pharmacokinetic- AUC0-last

  Up to 8 days

• Pharmacokinetic- AUC0-inf

  Up to 8 days

• Pharmacokinetic- λz

  Up to 8 days

Study Arms (1)

[14C]-RPC1063 Solution (0.1 g/mL)

EXPERIMENTAL

1 mg; 10 mL \[14C\]-RPC1063 HCl oral dose containing NMT 1.3 MBq (37 μCi) 14C

Drug: RPC1063

Interventions

RPC1063 DRUG

[14C]-RPC1063 Solution (0.1 g/mL)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is male
• Subject is 30 to 65 years of age
• 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
• Subject is willing and able to communicate and participate in the whole study
• Subject has regular bowel movements (average stool production ≥1 and ≤3 stools per day)
• Subject has suitable veins for multiple cannulation as assessed by the investigator at screening
• Subject is able to comprehend the informed consent form, provide written informed consent, and able to comply with requirements of the study.
• Subject agrees to use an adequate method of contraception

You may not qualify if:

• Subject has received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months
• Subject is a study site employee or an immediate family member of a study site or sponsor employee
• Subject has a history of any drug or alcohol abuse in the past 2 years
• 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)
• 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 admission
• Subject has radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (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
• Subjects has been enrolled in an absorption, distribution, metabolism and elimination (ADME) study in the last 12 months
• Subject has clinically significant abnormal biochemistry or haematology as judged by the investigator
• Subject has positive drugs of abuse test result
• Subject has positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
• Subject has evidence of renal impairment at screening and admission, as indicated by an estimated creatinine clearance (CLcr) of \<90 mL/min using the Cockcroft-Gault equation
• Subject has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) concentration \>1.25 × the ULN at screening
• Subject has history of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
• Subject has had serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Subject has presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

ozanimod

Study Officials

• Jonathan Tran, Pharm.D

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 15, 2016
• Study Start: October 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

GB (1)