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Vatalinib

Phase 1

Undisclosed | Small molecule | Other |Novartis AG|Trials Updated: Nov 19, 2009

Vatalinib development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Vatalinib clinical trials

Vatalinib · 1 trial · 1 indication

Phase 1 1
NCT00426452A Drug-drug Interaction Study of Oral 1250 mg of Vatalinib Administered Under Fasting and Fed Conditions With a Proton-pump Inhibitor in Healthy Sterile or Postmenopausal Female VolunteersHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
A Drug-drug Interaction Study of Oral 1250 mg of Vatalinib Administered Under Fasting and Fed Conditions With a Proton-pump Inhibitor in Healthy Sterile or Postmenopausal Female Volunteers
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Study Endpoints

Primary Endpoints

Assess the effect of multiple doses of a proton-pump inhibitor on the pharmacokinetics of a single dose of Vatalinib under fasting and fed conditions.

Secondary Endpoints

Safety of a single dose of Vatalinib before and after a proton-pump inhibitor under fasting and fed conditions as assessed by adverse events, laboratory values, electrocardiograms, and vital signs.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
VatalinibDRUG -
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Eligibility Criteria

Age Range35 Years to 70 Years
SexFEMALE
Healthy VolunteersNo

Inclusion criteria * Healthy female * Surgically sterile or post-menopausal * At least a weight of 50 kg and have a body mass index (BMI) ≤33.0 * Non-smokers or those who smoke 25 cigarettes or less per day Exclusion criteria * Use of certain prescription and over the counter drugs * Having receive...

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Frequently asked questions about Vatalinib

What is Vatalinib?

Vatalinib is an investigational small molecule kinase inhibitor developed by Novartis AG. It has been studied in a Phase 1 drug-drug interaction trial in healthy sterile or postmenopausal female volunteers. Vatalinib has not been approved by the FDA and remains in clinical development.

What does Vatalinib target?

Vatalinib is a small molecule kinase inhibitor, belonging to the -nib class of drugs that act on kinase enzymes. Kinase inhibitors work by blocking the activity of specific kinases involved in cellular signaling pathways. The specific molecular target of vatalinib has not been publicly disclosed.

Who makes Vatalinib?

Vatalinib is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker symbol NVS. Novartis is a multinational pharmaceutical company headquartered in Switzerland.

What phase is Vatalinib in?

Vatalinib is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not received FDA approval.

What clinical trials is Vatalinib in?

Vatalinib has been evaluated in one completed Phase 1 trial, NCT00426452. This drug-drug interaction study examined oral vatalinib at 1250 mg administered under fasting and fed conditions with a proton-pump inhibitor in healthy sterile or postmenopausal female volunteers. The trial enrolled 24 participants and was randomized but uncontrolled.