A Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery and Pharmacokinetics of 14C TZP-101

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Ileus
• Intervention / Treatment: Drug: TZP-101

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Nottingham, England, United Kingdom, NG11 6JS
      • Quotient Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy Males
• 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
• Must be willing and able to communicate and participate in the whole study
• Must provide written informed consent
• Subject must agree to use adequate methods of contraception

Exclusion Criteria:

• Participation in a clinical research study within the previous 3 moths or more than 3 studies within the previous 12 months
• Participation in an ADE study within the previous 12 months
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption >21 units per week
• 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
• Radiation exposure from clinical studies, including that from the present study, excluding background radiation including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
• 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
• PR interval 220 ms at screening or on admission
• QTcB >450 ms at screening or on admission
• Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the IMP
• History or presence of significant cardiovascular, respiratory, gastrointestinal (especially peptic ulcer disease), neurological, psychiatric, metabolic, hepatic or renal problems as judged by the investigator
• Positive drugs of abuse test result
• Positive HBV, HCV or HIV results
• Use of prescription or non prescription drugs, including vitamins, herbal and dietary supplements (including St. John's Wort) within 14 days of the planned IMP administration unless in the opinion of the PI the medication will not interfere with study procedures or compromise study safety
• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
• Presence or history of allergy requiring treatment (seasonal allergic rhinitis (hayfever) is allowed unless it is active)
• Donation or loss of greater than 400 mL of blood within the previous three months
• Subjects receiving or requiring prohibited medication as described in Section 11
• Failure to satisfy the Investigator of fitness to participate for any other reason
• Poor venous access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 14C TZP-101	Drug: TZP-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of total radioactivity in plasma	To determine the pharmacokinetics of total radioactivity in plasma (Cmax, tmax, AUC, t1/2)	6 weeks
Pharmacokinetics of parent TZP-101 in plasma	To determine the pharmacokinetics of parent TZP-101 in plasma (Cmax, tmax, AUC, t1/2)	6 weeks
Total radioactivity in urine and faeces	To determine the Urine and faecal recovery of total radioactivity (Ae, Fe%, CLr)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total radioactivity in plasma	To determine the Total radioactivity in plasma/total radioactivity in whole blood ratio at selected timepoints	6 weeks
Total radioactivity of parent drug in plasma	To determine the Total radioactivity in plasma/parent drug in plasma ratio for selected PK parameters	6 weeks

Collaborators and Investigators

• Sponsor: Norgine
• Investigators: Principal Investigator: Philip Evans, MD, Quotient Clinical, Mere Way, Ruddlington Fields, Nottingham

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): March 1, 2012

Study Registration Dates

• First Submitted: August 8, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (ESTIMATE): August 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 17, 2012
• Last Update Submitted That Met QC Criteria: August 16, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: NPJ5004-03/2011 (MET)