Status:
COMPLETED
Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin
Lead Sponsor:
GlaxoSmithKline
Conditions:
Osteoarthritis
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief Summary
Relacatib is being developed for the treatment of osteoporosis, osteoarthritis and possibly other bone disorders. Recent results suggest that relacatib interacts with the way our bodies metabolise dru...
Eligibility Criteria
Inclusion
- Healthy
- Postmenopausal
- Body weight \> 50 kg
- Body mass index (BMI) between 19 and 30
- The subject is willing and able to give a signed and dated written informed consent prior to admission to the study
- The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Exclusion
- Subjects with known morphea or sclerodermia
- Subjects with a history of myocardial infarction.
- Subjects with a history of renal/or hepatic disease unless the disease has been successfully treated and is no longer active; subjects with any evidence of renal/ or hepatic impairment on the screening physical and laboratory examination.
- Subjects with history of hypertension or systolic blood pressure
- Subjects with history of diabetes
- History of regular alcohol consumption exceeding 7 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening.
- History of use of tobacco- or nicotine-containing products within 6 months of screening, or a positive urine cotinine indicative of smoking at screening.
- Positive urine drug screen including alcohol (or alcohol breath test) at screening.
- Positive for HIV, hepatitis B virus or hepatitis C virus.
- Donation of blood in excess of 500 mL within 56 days prior to dosing
- History of sensitivity or contraindications to any of the study medications (i.e., relacatib, paracetamol, ibuprofen or atorvastatin) or components thereof.
- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- Subjects whom are judged by the investigator to be at risk for acute angle closure glaucoma.
Key Trial Info
Start Date :
October 19 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2006
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00411190
Start Date
October 19 2006
End Date
December 15 2006
Last Update
October 4 2017
Active Locations (2)
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1
GSK Investigational Site
Antwerp, Belgium, 2060
2
GSK Investigational Site
Liège, Belgium, 4000