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

NCT01668199 | Completed Phase 1

• 1 other identifier: NPJ5004-03/2011 (MET)
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Postoperative Ileus

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics of total radioactivity in plasma

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

  6 weeks

• Pharmacokinetics of parent TZP-101 in plasma

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

  6 weeks

• Total radioactivity in urine and faeces

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

  6 weeks

Secondary Outcomes (2)

• Total radioactivity in plasma

  6 weeks

• Total radioactivity of parent drug in plasma

  6 weeks

Study Arms (1)

14C TZP-101

EXPERIMENTAL

Drug: TZP-101

Interventions

TZP-101 DRUG

14C TZP-101

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy Males
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

Quotient Clinical

Nottingham, England, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

ulimorelin

Study Officials

• Philip Evans, MD

  Quotient Clinical, Mere Way, Ruddlington Fields, Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 17, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: August 17, 2012

Record last verified: 2012-08

Locations

GB (1)