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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00468689

Purpose

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.

Condition	Intervention	Phase
Osteoporosis	Drug: SB-751689 oral tablets (100 and 400 ng) Drug: Ketoconazole (NIZORAL) oral tablets (200 mg)	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind Primary Purpose: Treatment
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Ketoconazole Fungarest

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 Outcome Measures:

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 ]

Enrollment:	15
Study Start Date:	April 2007
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Other Names:

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

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468689

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00468689 History of Changes
Other Study ID Numbers:	CR9107262
Study First Received:	May 1, 2007
Last Updated:	October 9, 2008
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

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

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ketoconazole
14-alpha Demethylase Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012