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

NCT00411190 | Completed Phase 1

• 1 other identifier: SB-462795/008
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Postmenopausal; Osteoporosis

Outcome Measures

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.

  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.

  Up to Day 17

Study Arms (2)

Session 1

EXPERIMENTAL

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

Drug: Acetaminophen; Drug: Ibuprofen; Drug: Atorvastatin

Session 2

EXPERIMENTAL

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; Drug: Acetaminophen; Drug: Ibuprofen; Drug: Atorvastatin

Interventions

Relacatib DRUG

Subjects will administer 60 or 120 mg tablets in Session 2

Session 2

Acetaminophen DRUG

Acetaminophen will be administered orally

Session 1; Session 2

Ibuprofen DRUG

Ibuprofen will be administered orally

Session 1; Session 2

Atorvastatin DRUG

Atorvastatin will be administered orally

Session 1; Session 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Antwerp, 2060, Belgium

Location

GSK Investigational Site

Liège, 4000, Belgium

Location

Related Links

• Results for study SB-462795/008 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Osteoarthritis; Osteoporosis

Interventions

relacatib; Acetaminophen; Ibuprofen; Atorvastatin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases, Metabolic; Bone Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2006
• First Posted: December 13, 2006
• Study Start: October 19, 2006
• Primary Completion: December 15, 2006
• Study Completion: December 15, 2006
• Last Updated: October 4, 2017

Record last verified: 2017-10

Locations

BE (2)