Mass Balance Study of [14C]-S-600918 Oral Suspension in Healthy Male Subjects
Phase 1
Completed
- Conditions
- Healthy subjects
- Registration Number
- JPRN-jRCT1080225285
- Lead Sponsor
- Shionogi B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 6
Inclusion Criteria
Healthy male subjects
Exclusion Criteria
Subjects who are considered ineligible for this study by the investigator or subinvestigator due to current or history of clinically significant metabolic or endocrine, cardiovascular, renal, hepatic, hematological, urological, immunological, pulmonary, respiratory or gastrointestinal disease, neurological or psychiatric disorderor, or other clinically significant diseases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method pharmacokinetics<br>- Total radioactivity (TR) in all excreta (urine and faeces): Cumulative amount of TR excreted in excreta (CumAe) and CumAe expressed as a percentage of the radioactive dose administered (Cum%Ae)<br>- Concentrations of TR in whole blood and plasma<br>- Pharmacokinetics (PK) parameters for TR, S-600918 and S-600918 acyl glucuronide in plasma for TR in whole blood including but not limited to: time to maximum concentration (Tmax), maximum concentration (Cmax), and area under the concentration-time curve (AUC)
- Secondary Outcome Measures
Name Time Method safety<br>pharmacokinetics<br>- Amount of TR excreted in excreta (Ae) and Ae expressed as a percentage of the radioactive dose administered (%Ae), CumAe and Cum%A by interval in urine, faeces, and urine and faeces combined, and appropriate PK parameters of TR, S-600918 and S-600918 acyl glucuronide in plasma and TR in whole blood.<br>- Each metabolite accounting for more than 5% (in plasma) by AUC of circulating TR and each metabolite in excreta (urine and faeces) that account for more than 10% of the administered radioactive dose<br>- Whole blood:plasma concentration ratios for TR.<br>- Adverse events (AEs), vital signs, ECGs, physical examinations and laboratory safety tests.