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

October 9, 2008 updated by: GlaxoSmithKline

A Two-Part Dose-Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SB-751689 When Administered as an Oral Formulation at Supratherapeutic Dose Levels in Healthy Adult Subjects.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
throughout the study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 1, 2007

First Submitted That Met QC Criteria

May 1, 2007

First Posted (Estimate)

May 3, 2007

Study Record Updates

Last Update Posted (Estimate)

October 13, 2008

Last Update Submitted That Met QC Criteria

October 9, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR9107262

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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