Last updated: 11/04/2018 11:31:18
Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A study to evaluate the potential for pharmacokinetic interaction between SB 462795 and SSRIs in healthy subjects [3A]
Trial description: 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 drugs and so some drugs which are commonly prescribed to the intended target patient population could be affected by giving relacatib at the same time. The purpose of this study is to evaluate the effect of repeat dose administration of relacatib on the way subjects bodies metabolise three commonly prescribed medications in the osteoarthritis population: ibuprofen, acetaminophen, and atorvastatin.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
The primary objective of this study is to characterize the effect of relacatib at steady-state on the pharmacokinetics of a single oral dose of acetaminophen, ibuprofen and atorvastatin in healthy postmenopausal females.
Timeframe: Up to Day 17
Secondary outcomes:
To assess the safety and tolerability of the concomitant administration of oral doses of relacatib and acetaminophen, ibuprofen and atorvastatin. To describe the changes from baseline in serum CTXI levels for each relacatib dose tested.
Timeframe: Up to Day 17
Interventions:
Drug: Relacatib
Drug: Acetaminophen
Drug: Ibuprofen
Drug: Atorvastatin
Enrollment:
32
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Osteoarthritis
Product
relacatib
Collaborators
Not applicable
Study date(s)
October 2006 to December 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female
Age
18 - 70 years
Accepts healthy volunteers
Yes
- Healthy
- Postmenopausal
- Subjects with known morphea or sclerodermia
- Subjects with a history of myocardial infarction.
Inclusion and exclusion criteria
Inclusion criteria:
- 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 criteria:
- 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-15-12
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
Participate in clinical trial
Additional information
Results for study SB-462795/008 can be found on the GSK Clinical Study Register.
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