A Study To Investigate The Metabolism And Excretion Of 14C SB-751689 Given To Healthy Males And Postmenopausal Women

NCT00499928 | Completed Phase 1

• 1 other identifier: CR9106327
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the biological fate of radioactive SB-751689 administered to healthy males and healthy postmenopausal women. Subjects will receive a single oral dose of radioactive SB-751689. Excreta and blood samples will be taken over the course of 7 days. This study will help determine the major route of elimination of SB-751689 in humans. It will also provide samples (blood, plasma, urine, and stools) for analysis of metabolites, if any.

Conditions

Osteoporosis

Keywords

SB-751689; osteoporosis; metabolism; excretion

Outcome Measures

Primary Outcomes (1)

• The total amount of administered radioactivity recovered in excreta and the primary route of excretion over 7 days

  over 7 days

Secondary Outcomes (1)

• The amount of radioactivity associated with blood vs. plasma. The total amount radioactivity vs. SB-751689 radioactivity (metabolite vs. parent) over 7 days

  over 7 days

Interventions

SB-751689 DRUG

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult males of age 35 to 65 years, inclusive, or healthy ambulatory postmenopausal women defined as being amenorrheic for at least 2 years and 40 to 65 years of age, inclusive, at screening with FSH levels consistent with menopause. Healthy postmenopausal women, who are between ages 40 to 50 years, inclusive, must also have a documented history of bilateral oophorectomy (with or without hysterectomy) and be at least 6 weeks post-surgery.)
• Non-smokers
• Body weight \> or = 50 kg and BMI within the range 19 - 32 kg/m2
• A history of regular bowel movements
• Capable of giving written informed consent

You may not qualify if:

• Any clinically relevant biological or physical abnormality found or reported at screening which, in the opinion of the investigator, is clinically significant and would preclude safe participation in this study
• QTc interval of \> 450 msec at screening
• Positive urine drug screen at screening
• Positive urine test for alcohol at pre-dose
• Positive for HIV at screening
• Chronic hepatitis B and C, as evidenced by positive Hepatitis B surface antigen or Hepatitis C antibody
• Urinary cotinine levels indicative of smoking at screening
• History of smoking or use of nicotine containing products within one year of the study or \>10 pack-year history of smoking overall
• History of regular alcohol consumption exceeding 7 units/week for women and 14 units/week for men within 6 months of screening
• History of drug abuse within 6 months of the study
• Participation in a clinical study and received a drug or a new chemical entity with 30 days or 5 half-lives, or twice the duration of the biological effect of any drug prior to the first dose of the current study medication
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day
• Subjects who have received a total body radiation dose of greater than 5.0 mSv or exposure to significant radiation in the 12 months prior to this study
• Radiation exposure from the previous 3 year period is over 10 mSv for subjects who have been exposed to ionizing radiation above background as a result of their work with radiation as category A workers or as a result of research studies they may have been involved in. Clinical exposure will not be included
• Condition that could interfere with the accurate assessment and recovery of radiocarbon \[14C\]

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• GSK Clinical Trials, M.D.

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: April 1, 2007
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: May 18, 2009

Record last verified: 2009-05

Locations

US (1)