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Bioavailability of [14C]-SK-1404 ADME & IV Microtracer Study

NCT02878096 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-10-14

No results posted yet for this study

Summary

The primary objectives of the study are:

* To determine the absolute bioavailability of SK-1404
* To assess the mass balance recovery after a single oral (PO) dose of carbon-14 (14C)-SK-1404
* To provide plasma, urine and faecal samples for metabolite profiling and structural identification

The secondary objectives of the study are:

* To determine the routes and rates of elimination of \[14C\]-SK-1404
* To identify the chemical structure of each metabolite with an exposure (AUC) of more than 10% of circulating total radioactivity
* To explore the intravenous (IV) pharmacokinetics (PK) of \[14C\]-SK-1404
* To further explore the PO PK of SK-1404
* To provide additional safety and tolerability information for SK-1404

Conditions

  • Nocturia

Interventions

DRUG

[14C]-SK-1404

In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of \[14C\]-SK-1404.

Sponsors & Collaborators

  • Sanwa Kagaku Kenkyusho Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Litza McKenzie, MBChB BScMedSci · Quotient Clinical

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United Kingdom

Study Locations

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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 NCT02878096 on ClinicalTrials.gov