Phase I Study to Evaluate the Safety and Pharmacokinetics of Oral Doses of Anvylic-3288 in Healthy Subjects (AVL3288)
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|ClinicalTrials.gov Identifier: NCT01851603|
Recruitment Status : Terminated (PI left institution)
First Posted : May 10, 2013
Last Update Posted : December 30, 2016
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Device: AVL-3288 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase I, Single-center, Inpatient, Randomized, Double-blind, Placebo-controlled, Dose Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profiles of Single Oral Doses of AVL-3288 (Anvylic-3288) Healthy Subjects.|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Oral administration of AVL-3288
Other Name: UCI-4083
Placebo Comparator: Sugar pill
Identical diluent to that used for AVL-3288
Other Name: Diluent solution
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 48 hours ]0,1,2,3, 4, 6, 8 ,12, 24, 48 hours post dose
- Number of participants with adverse events. [ Time Frame: 10 days ]Corrected QT interval > 500 ms; hepatic enzyme > 3 times above the upper limit of normal values; systolic blood pressure > 200 mm Hg or diastolic blood pressure < 50 mm Hg.
- Repeatable Battery for Assessment of Neuropsychological Status Total Scale T Score [ Time Frame: 24 hours ]T score on Total Scale of the Repeatable Battery for Assessment of Neuropsychological Status, differences between AVL-3288 or placebo arms and pretreatment baseline.
- P50 Auditory Sensory Gating Ratio [ Time Frame: 24 hours ]Ratio = (Conditioning P50 amplitude-Test P50 Amplitude)/Conditioning P50 Amplitude, differences between AVL-3288 or placebo arms from baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851603
|United States, Colorado|
|U of Colorado Denver|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Robert Freedman, MD||U of Colorado Denver|