A Phase 1, Open-label, Single Intravenous Infusion Dose Study to Evaluate the Mass Balance, Pharmacokinetics, Metabolism, and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954)in Healthy Male Subjects
Completed
- Conditions
- Gastrointestinal motility disorders10017943
- Registration Number
- NL-OMON46703
- Lead Sponsor
- Millennium Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
Inclusion Criteria
-healthy male subjects
-18-55 yrs, inclusive
-BMI: >=18 and <=30 kg/m2 and a body weight >50 kg at the screening visit.
-non-smoking
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To determine the mass balance and routes of elimination of a single IV dose of<br /><br>TAK-954 containing microtracer ([14C]-TAK-954).<br /><br><br /><br>To characterize the metabolic profiles following single-dose IV administration<br /><br>of TAK-954 containing microtracer ([14C]-TAK-954) and identify major<br /><br>circulating and excreted metabolites.<br /><br><br /><br>To determine the single-dose pharmacokinetics (PK) of total radioactivity,<br /><br>TAK-954, THRX513466, and THRX 913682, where possible.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective of the study is to evaluate the safety and tolerability<br /><br>of a single IV dose of TAK-954 containing microtracer ([14C]-TAK-954) in<br /><br>healthy male subjects.</p><br>