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

Primary Purpose

Osteoarthritis

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Relacatib

Acetaminophen

Ibuprofen

Atorvastatin

About this trial

This is an interventional diagnostic trial for Osteoarthritis focused on measuring Osteoarthritis, Postmenopausal, Osteoporosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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Subjects with a history of renal/or hepatic disease unless the disease has been successfully treated and is no longer active; subjects with any evidence of renal/ or hepatic impairment on the screening physical and laboratory examination.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

Sites / Locations

GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Session 1

Session 2

Arm Description

Subjects will receive 500 mg acetaminophen on Day 1, 400 mg ibuprofen on Day 2, 40 mg atorvastatin on Day 3.

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.

Outcomes

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.

Full Information

NCT ID

NCT00411190

First Posted

December 11, 2006

Last Updated

October 2, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00411190

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

October 19, 2006 (Actual)

Primary Completion Date

December 15, 2006 (Actual)

Study Completion Date

December 15, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

Osteoarthritis, Postmenopausal, Osteoporosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Session 1

Arm Type

Experimental

Arm Description

Subjects will receive 500 mg acetaminophen on Day 1, 400 mg ibuprofen on Day 2, 40 mg atorvastatin on Day 3.

Arm Title

Session 2

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Relacatib

Intervention Description

Subjects will administer 60 or 120 mg tablets in Session 2

Intervention Type

Drug

Intervention Name(s)

Acetaminophen

Intervention Description

Acetaminophen will be administered orally

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Intervention Description

Ibuprofen will be administered orally

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Intervention Description

Atorvastatin will be administered orally

Primary Outcome Measure Information:

Title

Time Frame

Up to Day 17

Secondary Outcome Measure Information:

Title

Time Frame

Up to Day 17

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

GSK Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

12. IPD Sharing Statement

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

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