Last updated: 11/04/2018 06:01:57
Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.
GSK study ID
CR9107262
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
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
Timeframe: throughout the study
Secondary outcomes:
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.
Timeframe: throughout the study
Interventions:
Drug: SB-751689 oral tablets (100 and 400 ng)
Drug: Ketoconazole (NIZORAL) oral tablets (200 mg)
Enrollment:
15
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Osteoporosis
Product
ronacaleret
Collaborators
Not applicable
Study date(s)
April 2007 to August 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 60 Years
Accepts healthy volunteers
Yes
- Healthy adults aged 18-60yrs, with BMI of 19-31kg/m2.
- Females must be of non-childbearing potential.
- Clinically relevant abnormality from history, physical, 12-lead ECG, Holter monitoring, or clinical laboratory examination.
- Positive urine drug screen.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21225
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-06-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website