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

NCT ID: NCT01448395

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2011-11-30

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

[14C]NXL104

Intervention Type: DRUG

500mg/100mL intravenous solution

Interventions

[14C]NXL104

500mg/100mL intravenous solution

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Newell, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Study site

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1454&filename=D4280C00008_CSP-Redacted.pdf

Redacted CSP

Other Identifiers

D4280C00008

Identifier Type: -

Identifier Source: org_study_id