Evaluation Of SB-751689 Administered At Supratherapeutic... | NCT00468689

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

NCT00468689

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 13, 2008Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Osteoporosis

Interventions

SB-751689 oral tablets (100 and 400 ng)
Ketoconazole (NIZORAL) oral tablets (200 mg)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Apr 2007

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

May 1, 2007

First Submission Date that Met QC Criteria

May 1, 2007

First Posted Date

May 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2008

Last Update Posted Date

Oct 13, 2008Estimated

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Name	Type	Description	Arm Group Labels	Other Names
SB-751689 oral tablets (100 and 400 ng)	Drug
Ketoconazole (NIZORAL) oral tablets (200 mg)	Drug			SB-751689 oral tablets (100 and 400 ng)

Outcomes Module

Primary Outcomes

Measure	Description	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		throughout the study

Secondary Outcomes

Measure	Description	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.		throughout the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

ID	Term
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds