Trials / Completed
CompletedNCT03500224
A Study to Evaluate the Mass Balance, Pharmacokinetics (PK), Metabolism and Excretion of TAK-954 Containing Microtracer ([14C]-TAK-954) in Healthy Male Participants
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 Adult Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Millennium Pharmaceuticals, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine the mass balance, routes of elimination and characterize the metabolic profiles of a single intravenous dose of \[14C\]-TAK-954, identify major circulating and excreted metabolites. This study will also determine the single-dose PK of total radioactivity, TAK-954 and its metabolites where possible.
Detailed description
The drug being tested in this study is called TAK-954. This study will assess the mass balance, metabolic profiles and routes of elimination of single intravenous dose of \[14C\]-TAK-954, and will determine the major circulating and excreted metabolites and single-dose PK of total radioactivity, TAK-954, THRX513466, and THRX 913682 in healthy male participants. The study will enroll approximately 6 participants. All participants will receive a single dose of \[14C\]-TAK-954 0.5 mg on Day 1. This single-center trial will be conducted in Netherlands. The overall time to participate in this study is approximately 6 to 7 weeks. Participants will make a final visit to the clinic 15 days after last dose of study drug for a follow-up assessment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [14C]-TAK-954 | \[14C\]-TAK-954 intravenous infusion. |
Timeline
- Start date
- 2018-04-30
- Primary completion
- 2018-06-01
- Completion
- 2018-06-01
- First posted
- 2018-04-18
- Last updated
- 2019-07-29
- Results posted
- 2019-07-29
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT03500224. Inclusion in this directory is not an endorsement.