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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Norgine
ClinicalTrials.gov Identifier:
NCT01668199
First received: August 8, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Postoperative Ileus
Drug: TZP-101
Phase 1

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

Further study details as provided by Norgine:

Primary Outcome Measures:
  • Pharmacokinetics of total radioactivity in plasma [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To determine the pharmacokinetics of total radioactivity in plasma (Cmax, tmax, AUC, t1/2)

  • Pharmacokinetics of parent TZP-101 in plasma [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To determine the pharmacokinetics of parent TZP-101 in plasma (Cmax, tmax, AUC, t1/2)

  • Total radioactivity in urine and faeces [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To determine the Urine and faecal recovery of total radioactivity (Ae, Fe%, CLr)


Secondary Outcome Measures:
  • Total radioactivity in plasma [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To determine the Total radioactivity in plasma/total radioactivity in whole blood ratio at selected timepoints

  • Total radioactivity of parent drug in plasma [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    To determine the Total radioactivity in plasma/parent drug in plasma ratio for selected PK parameters


Enrollment: 6
Study Start Date: February 2012
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 14C TZP-101 Drug: TZP-101

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668199

Locations
United Kingdom
Quotient Clinical
Nottingham, England, United Kingdom, NG11 6JS
Sponsors and Collaborators
Norgine
Investigators
Principal Investigator: Philip Evans, MD Quotient Clinical, Mere Way, Ruddlington Fields, Nottingham
  More Information

No publications provided

Responsible Party: Norgine
ClinicalTrials.gov Identifier: NCT01668199     History of Changes
Other Study ID Numbers: NPJ5004-03/2011 (MET)
Study First Received: August 8, 2012
Last Updated: August 16, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 22, 2014