Status:
COMPLETED
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
MALE
30-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01448395
Start Date
October 1 2011
End Date
November 1 2011
Last Update
September 1 2017
Active Locations (1)
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1
Study site
Ruddington, Nottingham, United Kingdom