Healthy Volunteers Clinical Trial
Official title:
A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults
Verified date | January 2017 |
Source | Celgene |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 30 Years to 65 Years |
Eligibility |
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 Exclusion Criteria: 1. Subject has received any investigational medicinal product (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 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 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 7. Subjects has been enrolled in an absorption, distribution, metabolism and elimination (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 and admission, as indicated by an estimated creatinine clearance (CLcr) of <90 mL/min using the Cockcroft-Gault equation 12. Subject has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) concentration >1.25 × the ULN 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Quotient Clinical | Nottingham |
Lead Sponsor | Collaborator |
---|---|
Celgene |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Pharmacokinetic- amount of drug excreted | Cumulative amount of drug excreted unchanged in the drug in urine | Up to 4 weeks | |
Secondary | Pharmacokinetic- Cmax | Maximum observed concentration | Up to 8 days | |
Secondary | Pharmacokinetic- Tmax | Time at maximum observed concentration | Up to 8 days | |
Secondary | Pharmacokinetic- AUC0-last | Area under the curve from 0 time to last measurable concentration | Up to 8 days | |
Secondary | Pharmacokinetic- AUC0-inf | Area under the curve from 0 time extrapolated to infinity | Up to 8 days | |
Secondary | Pharmacokinetic- ?z | Elimination rate constant | Up to 8 days | |
Secondary | Pharmacokinetic- t1/2 | Terminal elimination half-life | Up to 8 days | |
Secondary | Pharmacokinetic- CL/F | Clearance, the apparent volume cleared of parent drug per unit time after extravascular administration | Up to 8 days | |
Secondary | Pharmacokinetic- Vz/F | The apparent volume of distribution after extravascular administration | Up to 8 days | |
Secondary | Pharmacokinetic- CLr | Renal clearance | Up to 8 days | |
Secondary | Adverse Events (AEs) | Number of participants with adverse events | Approximately 2 months |
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