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Imatimib

Phase 1FDA approved 2001

Undisclosed | Gene therapy | Other |Novartis AG|Trials Updated: Jun 22, 2016

Imatimib development status

FDA approval May 10, 2001 as Gleevec
Approval holderNovartis
ApplicationNDA021335
Highest phase Phase 1

Imatimib target and mechanism

ModalityGene therapy

Also known as Imatimib Mesylate (Gleevec®), Gleevec®

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Imatimib clinical trials

Imatimib · 1 trial · 1 indication

Phase 1 1
NCT00446316Effect of Antacids on Gleevec® in Healthy VolunteersHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
Effect of Antacids on Gleevec® in Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

To define the effect of antacid administration on the pharmacokinetics (in particular the area under the Gleevec® plasma concentration versus time curve) of Gleevec® in healthy volunteers.
15 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Gleevec plus antacidsEXPERIMENTALGleevec® will be administered at a dose of 400 mg, and the antacid (Maximum Strength Maalox®Max® Antacid/Anti-gas) at a dose level of 20 mL (equivalent to 1600 mg aluminum hydroxide and 1600 mg magnesium hydroxide). Half of the subjects will receive Gleevec® and antacid on day 15 and Gleevec® alone on day 1.
Imatimib Mesylate (Gleevec®)EXPERIMENTALGleevec® will be administered at a dose of 400 mg. Half of the subjects will receive Gleevec® and antacid on day 15 and Gleevec® alone on day 1. The other half will be treated in reverse order, i.e., they will receive the combination of Gleevec® and antacid on day 1, and Gleevec® alone on day 15. The antacids will be administered 15 minutes before the Gleevec® dose.

Interventions

NameTypeDescription
Antacids (Mg-Al-based)DRUGthe antacid (Maximum Strength Maalox®Max® Antacid/Anti-gas) at a dose level of 20 mL (equivalent to 1600 mg aluminum hydroxide and 1600 mg magnesium hydroxide).
Imatimib Mesylate (Gleevec®)DRUGGleevec® will be administered at a dose of 400 mg. Half of the subjects will receive Gleevec® and antacid on day 15 and Gleevec® alone on day 1. The other half will be treated in reverse order, i.e., they will receive the combination of Gleevec® and antacid on day 1, and Gleevec® alone on day 15. The antacids will be administered 15 minutes before the Gleevec® dose.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men or women 18 years of age or older. Healthy subjects are defined as individuals who are free from clinically significant illness or disease (such as coronary arterial disease, chronic heart failure, bleeding disorder, hypertension, chronic renal failure etc.) as det...

Countries:United States
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Frequently asked questions about Imatimib

What is Imatimib?

Imatimib is an investigational gene therapy developed by Novartis AG under the ticker NVS. It has been studied in a Phase 1 clinical trial involving healthy adult volunteers in the United States. The specific medical conditions it is intended to treat have not been disclosed.

Who makes Imatimib?

Imatimib is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 1 trial of the therapy conducted in the United States. The company holds the development program for this gene therapy asset.

What phase is Imatimib in?

Imatimib is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The program enrolled 12 participants in a controlled, randomized study that was not double blinded.

What clinical trials is Imatimib in?

Imatimib has been studied in one completed Phase 1 trial, NCT00446316, titled Effect of Antacids on Gleevec in Healthy Volunteers. The trial enrolled 12 healthy adult participants of all sexes in the United States and used a controlled, randomized design without double blinding.

Is Imatimib the same as Imatimib Mesylate (Gleevec)?

Yes, Imatimib is also known as Imatimib Mesylate, marketed under the brand name Gleevec. The completed Phase 1 trial NCT00446316 was titled Effect of Antacids on Gleevec in Healthy Volunteers, confirming the connection between the Imatimib name and the Gleevec brand.