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

Postoperative Ileus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668199
• Other study ID #: NPJ5004-03/2011 (MET)
• Status: Completed
• Phase: Phase 1
• First received: August 8, 2012
• Last updated: August 16, 2012
• Start date: February 2012
• Est. completion date: March 2012

Study information

• Verified date: August 2012
• Source: Norgine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: March 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Ileus

Intervention

Drug:
• TZP-101

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham	England

Sponsors (1)

Lead Sponsor	Collaborator
Norgine

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of total radioactivity in plasma	To determine the pharmacokinetics of total radioactivity in plasma (Cmax, tmax, AUC, t1/2)	6 weeks	No
Primary	Pharmacokinetics of parent TZP-101 in plasma	To determine the pharmacokinetics of parent TZP-101 in plasma (Cmax, tmax, AUC, t1/2)	6 weeks	No
Primary	Total radioactivity in urine and faeces	To determine the Urine and faecal recovery of total radioactivity (Ae, Fe%, CLr)	6 weeks	No
Secondary	Total radioactivity in plasma	To determine the Total radioactivity in plasma/total radioactivity in whole blood ratio at selected timepoints	6 weeks	No
Secondary	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	No