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TAK-385 Phase I Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability Study

NCT02252354 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2016-10-27

Study results available
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Summary

The purpose of this 2 part study is to look at how TAK-385 is taken up, broken down and removed from the body when given as a radiolabelled oral solution (by mouth) or as an oral tablet (by mouth) followed by a radiolabelled intravenous (IV) infusion (into the arm vein).

Conditions

  • Healthy Volunteers

Interventions

DRUG

[14C]-TAK-385 Oral Solution

TAK-385 oral radiolabelled solution

DRUG

TAK-385 Tablets

TAK-385 tablets 2 X 40 mg

DRUG

[14C]-TAK-385 Solution for Intravenous Infusion

TAK-385 intravenous (IV) radiolabelled solution

Sponsors & Collaborators

Principal Investigators

  • Medical Director Clinical Science · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02252354 on ClinicalTrials.gov