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

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

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

Conditions
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Postoperative Ileus

Intervention / Treatment
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* Drug: TZP-101


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 14C TZP-101<br> | Drug: TZP-101<br> <br> |

What is the study measuring?
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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 |