Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104
NCT01448395
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Provision of informed consent prior to any study specific procedures.
- Healthy male subjects aged 30-65 years inclusive.
- Male subjects should be willing to use an adequate method of contraception (as defined in Section 5.1) from the day of dosing until 3 months after dosing with the investigational product.
- Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.
- Clinically normal physical examination and laboratory findings as judged by the investigator, including negative test results for drug abuse, alcohol, CO breath test and negative test results for Hepatitis B surface antigen, antibodies to Hepatitis C.
- Any clinically significant disease or disorder (e.g. cardiovascular, pulmonary,
gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic,
malignant, psychiatric, major physical impairment).
- Any clinically relevant abnormal findings in physical examination, vital signs,
clinical chemistry, haematology, urinalysis, which, in the opinion of the
investigator, may put the subject at risk because of his participation in the study.
- QTc > 450 ms or QT > 500 ms or other ECG abnormality making interpretation more
difficult, as judged by the investigator, or a history of additional risk factors for
Torsades de Points (eg heart failure, hypokalemia, family history of long QT
syndrome).
- Radiation exposure from clinical studies, including that from the present study,
excluding background radiation but including diagnostic X-rays and other medical
exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years.
- Participation in another clinical study with an investigational product during the
last 3 months.
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Descriptive Information | ||||
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Brief Title ICMJE | Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104 | |||
Official Title ICMJE | An Open Label Single-Dose Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104 | |||
Brief Summary | A study to look at how radiolabelled NXL104 is taken up, broken down and removed by the body when given as an injection into the blood stream. | |||
Detailed Description | An Open Label Single-Dose Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite profile and Metabolite Identification of [14C]NXL104. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE | Drug: [14C]NXL104
500mg/100mL intravenous solution | |||
Study Arms ICMJE | Experimental: 1
Intervention: Drug: [14C]NXL104 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 6 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2011 | |||
Actual Primary Completion Date | November 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 30 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01448395 | |||
Other Study ID Numbers ICMJE | D4280C00008 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | August 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |