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ABT-614

Phase 1

Healthy | Small molecule | Other |Abbott Laboratories|Last Updated: Aug 22, 2012

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

ABT-614 · 3 trials · 3 indications

Phase 1 3
NCT01464320A Study to Evaluate the Safety and Tolerability of ABT-614 and Its Effect on Kidney Function in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Protein in Their Urine.Type 2 Diabetics, Chronic Kidney Disease, Protein in Urine
COMPLETED16 Analytics
NCT00959816A Study to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in HumansHealthy
COMPLETED8 Analytics
NCT00788801Exploratory Positron Emission Tomography (PET) Study to Evaluate the Effects of ABT-614 on [11C]-(+)-PHNO Binding Potential to D3 Receptors in the BrainHealthy Volunteers
COMPLETED11 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety and Tolerability of ABT-614 and Its Effect on Kidney Function in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Protein in Their Urine.
Type 2 Diabetics, Chronic Kidney Disease, Protein in UrineUnlock trial analytics
PHASE1COMPLETED
A Study to Investigate the Process by Which ABT-614 is Absorbed, Distributed, Metabolized and Eliminated in Humans
HealthyUnlock trial analytics
PHASE1COMPLETED
Exploratory Positron Emission Tomography (PET) Study to Evaluate the Effects of ABT-614 on [11C]-(+)-PHNO Binding Potential to D3 Receptors in the Brain
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in drug concentration
Day -1 (Baseline) and up to Day 15

Blood and urine tests

Change in glomerular filtration rate
Day -1 (Baseline) and up to Day 15

Blood and urine tests

Safety and Tolerability Assessments (e.g., clinical laboratory tests, vital signs, adverse event assessment, physical examination)
One day before dosing through day of last dose and up to 72 hrs post-single dose or up to 14 days post-multiple doses
ABT-614 levels in cerebral spinal fluid
0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen
ABT-614 levels in blood (plasma)
0-24 hrs after single dose or 0-24 hrs after last dose of mulitple-dosing regimen
D3 receptor occupancy as estimated by measuring ABT-614 induced changes in [11C]-(+)-PHNO BP
At the approximate Tmax following a single dose of study drug

Secondary Endpoints

Change in urinary albumin excretion
Day -1 (Baseline) and up to Day 15
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABT-614EXPERIMENTAL -
Placebo ComparatorPLACEBO_COMPARATOR -
Single Dose (Part 1)EXPERIMENTAL -
Multiple Dose (Part 2)EXPERIMENTAL -
BaselineEXPERIMENTAL -
ABT-614 Low DoseEXPERIMENTAL -
ABT-614 High DoseEXPERIMENTAL -

Interventions

NameTypeDescription
ABT-614DRUGActive
Placebo ComparatorDRUGPlacebo
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Eligibility Criteria

Age Range19 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria 1. Male or female aged between 19 and 70 years, inclusive, at time of consent. 2. Type 2 diabetes receiving at least one anti-diabetic medication for at least one year at the time of Screening. 3. Hemoglobin A1c \< 12% at the time of Screening. 4. Estimated glomerular filtration ...

Countries:United StatesCanada
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Frequently asked questions about ABT-614

What is ABT-614 used for?

ABT-614 is an investigational small molecule being studied in healthy volunteers, type 2 diabetics, and patients with chronic kidney disease and protein in their urine. It has been evaluated in early-stage clinical trials for these conditions, though it is not approved for any use.

What does ABT-614 target?

ABT-614 is being studied for its effects on D3 receptors in the brain, as evaluated in a positron emission tomography (PET) study. The drug's interaction with these receptors was the focus of an exploratory trial in healthy volunteers.

Who makes ABT-614?

ABT-614 is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT.

What phase is ABT-614 in?

ABT-614 is in Phase 1 clinical development. All three completed trials for the drug were Phase 1 studies, and it remains an investigational agent not yet approved by regulatory authorities.

What clinical trials is ABT-614 in?

ABT-614 has been studied in three completed Phase 1 trials: NCT00788801, a PET study in healthy volunteers in Canada; NCT00959816, a study of drug absorption and elimination in healthy males in the United States; and NCT01464320, a safety and kidney function study in type 2 diabetics with chronic kidney disease and proteinuria.

Is ABT-614 the same as other names?

ABT-614 is the primary name used for this investigational drug in clinical trial registrations. No alternative names have been identified in the available clinical trial data.