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ABT-436

Phase 1

Healthy | Small molecule | Other |Abbott Laboratories|Last Updated: Nov 3, 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

Clinical trial landscape

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
Healthy
NCT0105012736
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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 used for?

ABT-436 is an investigational small molecule being studied for use in healthy adults. It is being developed by Abbott Laboratories and is currently in Phase 1 clinical development. The drug is not approved for any indication and is still in the early stages of clinical testing.

Who makes ABT-436?

ABT-436 is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The drug is currently in Phase 1 clinical development and is not yet approved for any use.

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 regulatory authorities. The drug is being studied in healthy volunteers to assess its safety, tolerability, and pharmacokinetics.

What clinical trials is ABT-436 in?

ABT-436 has one completed Phase 1 clinical trial, identified as NCT01050127. This study evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ABT-436 in healthy adults. The trial was conducted in the United States with 36 participants.

Is ABT-436 FDA approved?

ABT-436 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has completed a Phase 1 trial in healthy volunteers, but it has not been approved for any medical use.