Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00411190

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
Osteoporosis Osteoarthritis	Drug: Relacatib	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	An Open-Label, Two-Period, Fixed Sequence, Randomized, Parallel Group, Interaction Study to Determine the Effects of Repeat Doses of Relacatib on the Metabolism of Acetaminophen, Ibuprofen and Atorvastatin in Healthy Postmenopausal Female Subjects

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis Osteoporosis

Drug Information available for: Ibuprofen Acetaminophen Atorvastatin Atorvastatin calcium CT 2584 Relacatib

U.S. FDA Resources

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.

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.

Enrollment:	32
Study Start Date:	October 2006
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Other Name: Relacatib

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00411190 History of Changes
Other Study ID Numbers:	SB-462795/008
Study First Received:	December 11, 2006
Last Updated:	May 15, 2009
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by GlaxoSmithKline:

Osteoporosis
Osteoarthritis
Postmenopausal

Additional relevant MeSH terms:

Osteoarthritis
Osteoporosis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases, Metabolic
Bone Diseases
Acetaminophen
Ibuprofen
Atorvastatin
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites

ClinicalTrials.gov processed this record on February 09, 2012