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Completed

NCT Number: NCT00411190

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Subjects with a history of renal/or hepatic disease unless the disease has been successfully treated and is no longer active; subjects with any evidence of renal/ or hepatic impairment on the screening physical and laboratory examination.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.

Treatment and study plan

Relacatib

Drug

Subjects will administer 60 or 120 mg tablets in Session 2

Acetaminophen

Drug

Acetaminophen will be administered orally

Ibuprofen

Drug

Ibuprofen will be administered orally

atorvastatin

Drug

Atorvastatin will be administered orally

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Study to Evaluate the Potential for Pharmacokinetic Interaction Between SB 462795 and SSRIs in Healthy Subjects [3A]

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Dec 13, 2006
Registry last updated
Oct 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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