Recent Updates
Recently added Catalysts

Antacids

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: Jun 22, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Antacids · 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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Antacids

What is Antacids used for?

Antacids is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial evaluating its effects. The drug is being developed by Novartis AG, which trades on the NYSE under the ticker NVS.

Who makes Antacids?

Antacids is being developed by Novartis AG, a pharmaceutical company listed on the NYSE under the ticker NVS. The drug is currently in Phase 1 clinical development, with one completed trial in healthy volunteers.

What phase is Antacids in?

Antacids is in Phase 1 clinical development. It has one completed trial, NCT00446316, which enrolled 12 healthy volunteers in the United States. The drug is investigational and has not been approved by the FDA.

What clinical trials is Antacids in?

Antacids has one completed clinical trial, NCT00446316, titled "Effect of Antacids on Gleevec® in Healthy Volunteers." This Phase 1 study enrolled 12 healthy volunteers in the United States and was a controlled, randomized trial.

Is Antacids the same as Gleevec?

No, Antacids is not the same as Gleevec. The completed clinical trial NCT00446316 studied the effect of Antacids on Gleevec in healthy volunteers, indicating they are separate drugs. Antacids is an investigational small molecule developed by Novartis AG.