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Completed

NCT Number: NCT00468689

Evaluation Of SB-751689 Administered 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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Baltimore, Maryland, 21225, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SB-751689 oral tablets (100 and 400 ng)

Drug

Ketoconazole (NIZORAL) oral tablets (200 mg)

Drug

Other names: SB-751689 oral tablets (100 and 400 ng)

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

    Time frame: 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.

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
May 3, 2007
Registry last updated
Oct 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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