Postoperative IleusPhase 1NCT01668199
A Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery and Pharmacokinetics of 14C TZP-101
A Phase 1 study testing TZP-101 in people with Postoperative Ileus, run by Norgine at 1 site in United Kingdom.
Trial summary
A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- TZP-101
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to Mar 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.
- Conditions
- Postoperative Ileus
- Being tested
- TZP-101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TZP-101Drug
| Study group | Role | What they receive |
|---|---|---|
| 14C TZP-101 | Experimental | Not described Receives: Drug: TZP-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of total radioactivity in plasma
To determine the pharmacokinetics of total radioactivity in plasma (Cmax, tmax, AUC, t1/2)
Measured: 6 weeks
Pharmacokinetics of parent TZP-101 in plasma
To determine the pharmacokinetics of parent TZP-101 in plasma (Cmax, tmax, AUC, t1/2)
Measured: 6 weeks
Total radioactivity in urine and faeces
To determine the Urine and faecal recovery of total radioactivity (Ae, Fe%, CLr)
Measured: 6 weeks
Secondary outcomes (2)
Total radioactivity in plasma
To determine the Total radioactivity in plasma/total radioactivity in whole blood ratio at selected timepoints
Measured: 6 weeks
Total radioactivity of parent drug in plasma
To determine the Total radioactivity in plasma/parent drug in plasma ratio for selected PK parameters
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Evans, MD, Principal investigator, Quotient Clinical, Mere Way, Ruddlington Fields, Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668199
- Sponsor's protocol ID
- NPJ5004-03/2011 (MET)
- Status last verified
- Aug 2012
- First submitted
- 8 Aug 2012
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01668199
- Acronym / sponsor ID
- NPJ5004-03/2011 (MET)
- Conditions
- Postoperative Ileus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to investigate the mass balance recovery and pharmacokinetics of 14C TZP-101.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 14C TZP-101 | Experimental | Drug: TZP-101 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TZP-101 | Drug | 14C TZP-101 |
Primary outcome
Pharmacokinetics of total radioactivity in plasma
Time frame: 6 weeks
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
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
To determine the Urine and faecal recovery of total radioactivity (Ae, Fe%, CLr)
2 secondary outcomes
Total radioactivity in plasma
Time frame: 6 weeks
Total radioactivity of parent drug in plasma
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
Related trials for Postoperative Ileus
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Evans, MD principal investigator
Quotient Clinical, Mere Way, Ruddlington Fields, Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TZP-101 in people with Postoperative Ileus, run by Norgine at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of total radioactivity in plasma (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2012.