CClinicalTrials.gg
CompletedNCT00468689Updated Oct 13, 2008

Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.

A Phase 1 interventional study of SB-751689 oral tablets (100 and 400 ng) and Ketoconazole (NIZORAL) oral tablets (200 mg) in Osteoporosis, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-13.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study will evaluate the safety, tolerability and exposure of SB-751689 when administered alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable the planning and conduct of a QTc study for SB-751689.

02

Conditions studied

  • Osteoporosis

Browse trials for

Keywords

  • SB-751689,
  • Calcium-sensing receptor antagonist (CaR),
  • Osteoporosis,
  • Parathyroid hormone (PTH),
  • Oral dose
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 15 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adults aged 18-60yrs, with BMI of 19-31kg/m2.
  • Females must be of non-childbearing potential.
  • Subjects must be able to give consent and comply with restrictions of study.

Exclusion criteria

Exclusion Criteria:

  • Clinically relevant abnormality from history, physical, 12-lead ECG, Holter monitoring, or clinical laboratory examination.
  • Positive urine drug screen.
  • Positive urine test for alcohol.
  • Contine levels indicative of smoking.
  • Positive HIV or Hep B and/or C assay.
  • History or smoking in last year or >10 pack/year history of smoking overall.
  • History of regular alcohol consumption (7 units/week for women and 14 units/week for men) within 6 months of study.
  • History of drug abuse within 6 months of study.
  • Participation in another drug trial within 30 days of first dose.
  • Exposure to more than 4 new chemical entities within 12 months of first dose.
  • Use of prescription and non-prescription drugs including dietary supplements, herbals and St. John's wort within 14 days of first dose.
  • Consumption of red wine, grapefruit, grapefruit juice and grapefruit products within 14 days of first dose.
  • Donation of blood in excess of 500 mL within 56 days of dosing.
  • Evidence of renal, hepatic or biliary impairment.
  • History of serious gastrointestinal disease or history of gastrointestinal surgical procedure that might affect absorption of study drug.
  • History of sensitivity to any of the study medications.
  • History of clinically significant cardiovascular disease.
  • History of pernicious anemia, pancreatitis, osteosarcoma or kidney stones. Medical conditions which might alter bone metabolism.
  • Liver function tests above ULN at screening and PTH, glucose, and CPK outside the reference range at screening.
  • Males unwilling to refrain from fathering a child during the study and for 14 days following the last dose of study medication.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single
Enrollment
15 participants (actual)

Interventions

  • DrugSB-751689 oral tablets (100 and 400 ng)
  • DrugKetoconazole (NIZORAL) oral tablets (200 mg)

    Also known as: SB-751689 oral tablets (100 and 400 ng)

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of SB-751689 doses determined from clinical safety and tolerability data from all adverse event reporting, 12-lead ECGs, vital signs, nursing/physician observation, and safety laboratory tests

    Time frame: throughout the study

Secondary outcomes

  1. PK and of SB-751689 as determined by AUC, Cmax, tmax, and half-life. PD effects (PTH, serum Ca) as determined by AUC, Emax, tmax, maximum change and % change from baseline, duration of effect, duration above ULN for PTH.

    Time frame: throughout the study

07

Study locations

1 site
  • GSK Investigational Site
    Baltimore, Maryland 21225, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00468689
Lead sponsor
GlaxoSmithKline
First posted
May 3, 2007
Start date
Apr 2007
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Oct 13, 2008

Study contacts

GSK Clinical Trials, MD
study director · GlaxoSmithKline
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion