Completed

An Open-Label, Single-Dose, Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery and Pharmacokinetics of 14C TZP-101

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What is being tested

TZP-101

Drug
Who is being recruted

From 35 to 65 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2012
See protocol details

Summary

Principal SponsorNorgine
Last updated: August 17, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2012

Actual date on which the first participant was enrolled.

A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.

NCT01668199
Principal SponsorNorgine
Last updated: August 17, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 35 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate
35-65 years of age
Body Mass Index (BMI) of 18-32 kg/m2 or, if outside the range, considered not clinically significant by the investigator
Body weight of 75-90kg
Healthy Males
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21 exclusion criteria prevent from participating
Clinically significant abnormal biochemistry, haematology or urinalysis at screening as judged by the investigator
Clinically significant abnormal physical findings, ECG or vital signs measurements at screening
Current smokers and those who have smoked within the last 12 months, or a breath carbon monoxide (CO) reading of greater than 10ppm at screening
Donation or loss of greater than 400 mL of blood within the previous three months
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Quotient Clinical

Nottingham, United KingdomOpen Quotient Clinical in Google Maps
CompletedOne Study Center