Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoporosis
Intervention: SB-751689 oral tablets (100 and 400 ng) (Drug); Ketoconazole (NIZORAL) oral tablets (200 mg) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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.
Study design: Treatment, Randomized, Single Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Baltimore, Maryland 21225, United States
Additional Information
Starting date: April 2007
Ending date: August 2007
Last updated: June 18, 2008
|
