A Study to Estimate the Effect of Formulation on the Relative Absorption of SB-751689 Administered to Healthy Women

NCT00540878 | Completed Phase 1

• 1 other identifier: CR9108307
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effects of formulation on the relative bioavailability of SB-751689 (400 mg) administered to healthy postmenopausal women. Subjects will receive a single oral dose of each formulation, with five formulations of SB-751689 tested in total. Blood samples will be taken up to 24 hours postdose after each dose administration. This study will provide information for future possible formulation development of SB-751689 for Phase III.

Conditions

Osteoporosis

Keywords

Formulation Drug Study

Outcome Measures

Primary Outcomes (1)

• AUC and CMAX after a single dose.

  after a single dose

Secondary Outcomes (1)

• Safety and tolerability after single dose.

  after a single dose

Interventions

SB-751689 oral tablets (400 mg) DRUG

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy postmenopausal women; 40 and 65 years of age, inclusive

You may not qualify if:

• Body weight \> or = 50 kg and BMI within the range 19-32 kg/m2
• Capable of giving written informed consent and complying with the requirements and restrictions listed in the consent form
• 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
• A QTc interval of \> 450 msec at screening
• Positive urine drug screen at screening
• Positive urine test for alcohol at pre-dose
• Positive for HIV or hepatitis B or C virus at screening
• 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 (1 unit = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) 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 (whichever is longer) 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.
• Use of prescription or non-prescription drugs
• Consumption of red wine, grapefruit, grapefruit juice or grapefruit containing products within 14 days prior to the first dose of study medication

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Port Orange, Florida, 32127, 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 8, 2007
• Study Start: April 1, 2007
• Last Updated: May 18, 2009

Record last verified: 2009-05

Locations

US (1)