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Relacatib

Phase 1

Osteoarthritis | Small molecule | Musculoskeletal |GSK plc|Last Updated: Oct 4, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Relacatib · 1 trial · 1 indication

Phase 1 1
NCT00411190Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And AtorvastatinOsteoarthritis
COMPLETED32 Analytics
PHASE1COMPLETED
Study To Determine The Effects Of Doses Of Relacatib On The Metabolism Of Acetaminophen, Ibuprofen And Atorvastatin
OsteoarthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

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

Interventions

NameTypeDescription
RelacatibDRUGSubjects will administer 60 or 120 mg tablets in Session 2
AcetaminophenDRUGAcetaminophen will be administered orally
IbuprofenDRUGIbuprofen will be administered orally
AtorvastatinDRUGAtorvastatin will be administered orally
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Eligibility Criteria

Age Range18 Years to 70 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

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 requirem...

Countries:Belgium
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Frequently asked questions about Relacatib

What is Relacatib used for?

Relacatib is a small molecule being developed by GSK plc for osteoarthritis. It is currently in Phase 1 clinical development as an investigational therapy. The drug has been studied in a completed clinical trial involving patients with osteoarthritis.

Who makes Relacatib?

Relacatib is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is in Phase 1 clinical development for the treatment of osteoarthritis.

What phase is Relacatib in?

Relacatib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 clinical trial for the drug has been completed.

What clinical trials is Relacatib in?

Relacatib has been studied in one completed Phase 1 clinical trial, identified as NCT00411190. This trial examined the effects of Relacatib on the metabolism of acetaminophen, ibuprofen, and atorvastatin in patients with osteoarthritis.

Is Relacatib the same as GSK?

No, Relacatib is not the same as GSK. Relacatib is an investigational drug being developed by GSK plc, which is the company that makes the drug. GSK is the developer and manufacturer, while Relacatib is the drug candidate.