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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis; Osteoarthritis

Intervention: Relacatib (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: 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: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

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.

Locations and Contacts

GSK Investigational Site, Antwerpen 2060, Belgium

GSK Investigational Site, Liège 4000, Belgium

Additional Information

Starting date: October 2006
Last updated: May 15, 2009

Page last updated: August 20, 2015

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