A Double-Blind, Placebo Controlled, Single, Escalating Dose Study to Evaluate the Preliminary Pharmacokinetics, Safety and Tolerability of LNK-754 in Healthy Elderly Volunteers
NCT ID: NCT00903253
Last Updated: 2009-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2009-05-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
DOUBLE
Interventions
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LNK-754
Eligibility Criteria
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Inclusion Criteria
* Good general health as determined by medical history and physical examination
* Body Mass Index of 18-32, inclusive
* Estimate of creatinine clearance by Cockcroft-Gault that is normal for age and sex (greater than or equal to 60mL/min)
* Normal hemoccult test at screening and baseline
* Voluntarily consent to participate in the study
* Willing to adhere to the protocol requirements
Exclusion Criteria
* Subjects who have been diagnosed with or meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV\_TR) criteria for any significant psychiatric or psychoactive substance use disorder within the past year
* Subjects with positive urine drug screen or compounds associated with abuse in the absence of medical justification for their presence
* QTcB greater than 450 msec (males), or greater than 470 (females), based on the average interval of triplicate ECGs obtained after five minutes rest in a supine position using hte ECG algorithm
* Clinically significant abnormal screening results or laboratory tests
* Pregnant or nursing or planning a pregnancy, or planning on fathering a child
60 Years
75 Years
ALL
Yes
Sponsors
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Link Medicine Corporation
INDUSTRY
Locations
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CEDRA Clinical Research
Austin, Texas, United States
Countries
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Other Identifiers
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LNK754-0901-1A
Identifier Type: -
Identifier Source: org_study_id
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