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Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104

Last updated on March 14, 2019

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Study Location
Study site
Ruddington, Nottingham, United Kingdom
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01448395
Pfizer
Completed
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104

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