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

An Open-Label, Randomized, Five Period Crossover Study to Estimate the Relative Bioavailability of Five Formulations of 400mg SB-751689 (a Calcium-Sensing Receptor Antagonist) Administered as a Single Oral Dose to Healthy Postmenopausal Females

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00540878

Enrollment

Registered

2007-10-08

Start date

2007-04-30

Completion date

Unknown

Last updated

2009-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Formulation Drug Study

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.

Interventions

DRUGSB-751689 oral tablets (400 mg)

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy postmenopausal women; 40 and 65 years of age, inclusive * Non-smokers (as defined in

Exclusion criteria

6 below) * 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

Design outcomes

Primary

Measure	Time frame
AUC and CMAX after a single dose.	after a single dose

Secondary

Measure	Time frame
Safety and tolerability after single dose.	after a single dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026