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ABT-436

Phase 2

Undisclosed | Small molecule | Other |Abbott Laboratories|Trials Updated: Nov 3, 2010

ABT-436 development status

Highest phase Phase 2 run by AbbVie (prior sponsor, Abbott) (NCT01741142)
Phase scored for ABTPhase 1
Registered trials 4 across 4 sponsors since Jan 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

ABT-436 clinical trials

ABT-436 · 1 trial · 1 indication

Phase 1 1
NCT01050127A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy AdultsHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy Adults
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability Assessments (i.e., electrocardiogram(ECG), clinical laboratory tests, vital signs, weight, adverse events (AE) assessment, pulmonary function tests, physical and brief neurological examinations)
Days -2 through Day 7 or 14
Assess Pharmacokinetics (i.e., ABT-436 and possible metabolite levels)
Day -1 through Day 7
Pharmacodynamics (i.e., biomarkers of drug effect)
Day -1 through Day 7
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low dose ABT-436EXPERIMENTALABT-436 or placebo administered once daily for 7 days.
Mid Dose ABT-436EXPERIMENTALABT-436 or placebo administered once daily for 7 days.
High Dose ABT-436EXPERIMENTALABT-436 or placebo administered once daily for 14 days.

Interventions

NameTypeDescription
ABT-436DRUGSee Arm Description for details.
PlaceboDRUGSee Arm Description for details.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Age is between 18 and 55 years, inclusive. 2. If female, subject must be postmenopausal for at least two years or surgically sterile. 3. Females must have negative results for pregnancy tests prior to study drug administration. 4. If male, subject must be surgically sterile o...

Countries:United States
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Frequently asked questions about ABT-436

What is ABT-436?

ABT-436 is an investigational small molecule drug developed by Abbott Laboratories. It has been studied in a Phase 1 clinical trial in healthy adult volunteers to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics. The specific disease indications for ABT-436 have not been disclosed.

Who makes ABT-436?

ABT-436 is being developed by Abbott Laboratories, which trades on the New York Stock Exchange under the ticker symbol ABT. Abbott conducted the Phase 1 study of ABT-436 in the United States.

What phase is ABT-436 in?

ABT-436 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.

What clinical trials is ABT-436 in?

ABT-436 has been evaluated in one completed Phase 1 trial, NCT01050127, titled A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ABT-436 in Healthy Adults. The randomized, double-blind, controlled study enrolled 36 healthy adult participants in the United States.

What is ABT-436 used for?

ABT-436 has been studied in healthy adult volunteers rather than in patients with a specific disease. Its therapeutic indications have not been disclosed. The completed Phase 1 trial assessed safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses in 36 healthy participants.