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

Norgine

Status and phase

Completed

Phase 1

Conditions

Postoperative Ileus

Treatments

Drug: TZP-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT01668199

NPJ5004-03/2011 (MET)

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

Male

Ages

35 to 65 years old

Volunteers

Accepts Healthy Volunteers

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