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

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 - Microtracer TAK-954 Healthy Adult Male Subjects

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46703

Enrollment

Registered

2018-04-16

Start date

2018-04-30

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal motility disorders

Interventions

A total of 0.5 mg TAK-954 with trace amount of radioactivity will be given as an intravenous infusion over a 1-hour period during the morning of Day 1. When TAK-954 is given, the volunteer should ha

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -healthy male subjects -18-55 yrs, inclusive -BMI: >=18 and 50 kg at the screening visit. -non-smoking

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
To determine the mass balance and routes of elimination of a single IV dose of TAK-954 containing microtracer ([14C]-TAK-954). To characterize the metabolic profiles following single-dose IV administration of TAK-954 containing microtracer ([14C]-TAK-954) and identify major circulating and excreted metabolites. To determine the single-dose pharmacokinetics (PK) of total radioactivity, TAK-954, THRX513466, and THRX 913682, where possible.	—

Measure

Time frame

To determine the mass balance and routes of elimination of a single IV dose of TAK-954 containing microtracer ([14C]-TAK-954). To characterize the metabolic profiles following single-dose IV administration of TAK-954 containing microtracer ([14C]-TAK-954) and identify major circulating and excreted metabolites. To determine the single-dose pharmacokinetics (PK) of total radioactivity, TAK-954, THRX513466, and THRX 913682, where possible.

—

Secondary

Measure	Time frame
The secondary objective of the study is to evaluate the safety and tolerability of a single IV dose of TAK-954 containing microtracer ([14C]-TAK-954) in healthy male subjects.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)