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

Last updated on October 4, 2018

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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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
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.
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.
Interventional
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Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
November 2011
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • 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.
Sexes Eligible for Study: Male
30 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01448395
D4280C00008
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Paul Newell, MD AstraZeneca
Pfizer
August 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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