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ATF936

Phase 1

Undisclosed | Small molecule | Other |Novartis AG|Trials Updated: Jun 23, 2008

ATF936 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2006

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

ATF936 clinical trials

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.
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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 developed by Novartis AG. It has been studied in a Phase 1 clinical trial in healthy adult volunteers, and no therapeutic indication has been disclosed for the compound. It is not an approved medicine and remains in early clinical development.

Who makes ATF936?

ATF936 is made and developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 1 study of the compound conducted in the United States.

What phase is ATF936 in?

ATF936 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials of ATF936 are currently listed. The compound has not been approved by the FDA and remains investigational.

What clinical trials is ATF936 in?

ATF936 has been evaluated in one completed Phase 1 trial, NCT00417261, titled Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of Single and Multiple-Doses of ATF936 and AXT914 Administered Orally in Healthy Subjects. The trial enrolled 65 healthy adult volunteers in the United States and was randomized, double-blind, and placebo-controlled.

Was the ATF936 trial placebo-controlled?

Yes. The Phase 1 trial of ATF936, NCT00417261, was randomized, double-blind, and placebo-controlled. It enrolled 65 healthy volunteers aged 18 years and older of any sex in the United States and has been completed. The study examined single and multiple oral doses of ATF936 and AXT914.