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

Sponsor
Norgine (Industry)
Overall Status
Completed
CT.gov ID
NCT01668199
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
29
Duration (Days)
6.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Feb 1, 2012
Actual Study Completion Date :
Mar 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 14C TZP-101

Drug: TZP-101

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics of total radioactivity in plasma [6 weeks]

    To determine the pharmacokinetics of total radioactivity in plasma (Cmax, tmax, AUC, t1/2)

  2. Pharmacokinetics of parent TZP-101 in plasma [6 weeks]

    To determine the pharmacokinetics of parent TZP-101 in plasma (Cmax, tmax, AUC, t1/2)

  3. Total radioactivity in urine and faeces [6 weeks]

    To determine the Urine and faecal recovery of total radioactivity (Ae, Fe%, CLr)

Secondary Outcome Measures

  1. Total radioactivity in plasma [6 weeks]

    To determine the Total radioactivity in plasma/total radioactivity in whole blood ratio at selected timepoints

  2. Total radioactivity of parent drug in plasma [6 weeks]

    To determine the Total radioactivity in plasma/parent drug in plasma ratio for selected PK parameters

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Norgine
ClinicalTrials.gov Identifier:
NCT01668199
Other Study ID Numbers:
  • NPJ5004-03/2011 (MET)
First Posted:
Aug 17, 2012
Last Update Posted:
Aug 17, 2012
Last Verified:
Aug 1, 2012

Study Results

No Results Posted as of Aug 17, 2012