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ATF936

Phase 1

Healthy | Small molecule | Other |Novartis AG|Last Updated: Jun 23, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment65

FDA Designations

No designations recorded

Clinical trial landscape

ATF936 · 1 trial · 1 indication

Phase 1 1
NCT00417261Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of Single and Multiple-Doses of ATF936 and AXT914 Administered Orally in Healthy Subjects.Healthy
COMPLETED65 Analytics
PHASE1COMPLETED
Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of Single and Multiple-Doses of ATF936 and AXT914 Administered Orally in Healthy Subjects.
Healthy
NCT0041726165
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Study Endpoints

Primary Endpoints

Phase A: Safety and tolerability of single, oral doses of ATF936 and AXT914 under proposed conditions in healthy male and female subjects. Pharmacokinetics (PK) and pharmacodynamics (PD) of ATF936 and AXT914 in healthy male and female subjects.
Phase B: A head-to-head comparison of ATF936 and AXT914, each given at its pharmacologically effective dose as determined in Phase A.
Phase C: Similarity of PK/PD profile to single-dose profile after limited multiple dosing in healthy post-menopausal females. Early bone biomarker information after multiple dosing for best candidate as selected in Phase A or Phase B
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALATF936
2EXPERIMENTALAXT914
3PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
ATF936DRUG -
AXT914DRUG -
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Eligibility Criteria

Age Range18 Years to 68 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Study population: Open-label safety cohort, Phases A and B: Healthy male and female subjects between the ages 18 to 68 years (inclusive), in good health as determined by past medical history, physical examination, vital signs assessments, electrocardiograms, routine laboratory ...

Countries:United States
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Frequently asked questions about ATF936

What is ATF936?

ATF936 is an investigational small molecule being developed by Novartis AG. It is currently in Phase 1 clinical development. The drug has been studied in a completed clinical trial involving healthy subjects to evaluate its safety, tolerability, pharmacodynamic and pharmacokinetic effects.

What is ATF936 used for?

ATF936 is being studied for use in healthy subjects. The completed Phase 1 trial assessed the safety, tolerability, pharmacodynamic and pharmacokinetic effects of single and multiple doses of ATF936 administered orally. Its intended therapeutic use has not been specified.

Who makes ATF936?

ATF936 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical development.

What phase is ATF936 in?

ATF936 is in Phase 1 clinical development. The drug has completed one Phase 1 trial, which was a randomized, double-blind, placebo-controlled study in healthy subjects. It is not approved and remains investigational.

What clinical trials is ATF936 in?

ATF936 has been studied in one completed clinical trial, identified as NCT00417261. This Phase 1 study evaluated the safety, tolerability, pharmacodynamic and pharmacokinetic effects of single and multiple doses of ATF936 and AXT914 administered orally in healthy subjects in the United States.

Is ATF936 the same as AXT914?

ATF936 and AXT914 are distinct investigational drugs that were studied together in the same clinical trial, NCT00417261. The trial evaluated the safety, tolerability, pharmacodynamic and pharmacokinetic effects of both drugs administered orally in healthy subjects.