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

NCT00468689 | Completed Phase 1

• 1 other identifier: CR9107262
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

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

Outcome Measures

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

  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.

  throughout the study

Interventions

SB-751689 oral tablets (100 and 400 ng) DRUG

Ketoconazole (NIZORAL) oral tablets (200 mg) DRUG

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Ketoconazole

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 1, 2007
• First Posted: May 3, 2007
• Study Start: April 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: October 13, 2008

Record last verified: 2008-10

Locations

US (1)