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Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00411190
First Posted: December 13, 2006
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Osteoarthritis Drug: Relacatib Drug: Acetaminophen Drug: Ibuprofen Drug: Atorvastatin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study to Evaluate the Potential for Pharmacokinetic Interaction Between SB 462795 and SSRIs in Healthy Subjects [3A]

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. [ Time Frame: Up to Day 17 ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Up to Day 17 ]

Enrollment: 32
Actual Study Start Date: October 19, 2006
Study Completion Date: December 15, 2006
Primary Completion Date: December 15, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Session 1
Subjects will receive 500 mg acetaminophen on Day 1, 400 mg ibuprofen on Day 2, 40 mg atorvastatin on Day 3.
Drug: Acetaminophen
Acetaminophen will be administered orally
Drug: Ibuprofen
Ibuprofen will be administered orally
Drug: Atorvastatin
Atorvastatin will be administered orally
Experimental: Session 2
Subjects will be randomized to receive relacatib 60 mg or 120 mg from Day 1-14. On Day 15 subjects will receive 500 mg acetaminophen, 400 mg ibuprofen on Day 16 and 40 mg atorvastatin on Day 17 with usual dose of relacatib.
Drug: Relacatib
Subjects will administer 60 or 120 mg tablets in Session 2
Drug: Acetaminophen
Acetaminophen will be administered orally
Drug: Ibuprofen
Ibuprofen will be administered orally
Drug: Atorvastatin
Atorvastatin will be administered orally

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411190


Locations
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2060
GSK Investigational Site
Liège, Belgium, 4000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00411190     History of Changes
Other Study ID Numbers: SB-462795/008
First Submitted: December 11, 2006
First Posted: December 13, 2006
Last Update Posted: October 4, 2017
Last Verified: October 2017

Keywords provided by GlaxoSmithKline:
Osteoarthritis
Postmenopausal
Osteoporosis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Atorvastatin Calcium
Ibuprofen
Acetaminophen
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors