Clinical trial NCT01668199: A Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery and Pharmacokinetics of 14C TZP-101
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postoperative Ileus
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2012-08-17
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics of total radioactivity in plasma
timeFrame: 6 weeks
measure: Pharmacokinetics of parent TZP-101 in plasma
timeFrame: 6 weeks
measure: Total radioactivity in urine and faeces
timeFrame: 6 weeks
Secondary outcomes:
measure: Total radioactivity in plasma
timeFrame: 6 weeks
measure: Total radioactivity of parent drug in plasma
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical
state: England
Study officials:
affiliation: Quotient Clinical, Mere Way, Ruddlington Fields, Nottingham
name: Philip Evans, MD
role: PRINCIPAL_INVESTIGATOR
References: