Status:
COMPLETED
A Double-Blind, Placebo Controlled, Single, Escalating Dose Study to Evaluate the Preliminary Pharmacokinetics, Safety and Tolerability of LNK-754 in Healthy Elderly Volunteers
Lead Sponsor:
Link Medicine Corporation
Conditions:
Healthy Elderly Volunteers
Eligibility:
All Genders
60-75 years
Phase:
PHASE1
Brief Summary
The objective of this study is to evaluate the single-dose plasma pharmacokinetics of LNK-754 as well as safety and tolerability in normal healthy male and female elderly volunteers
Eligibility Criteria
Inclusion
- Males and Females aged 60 to 75 years
- 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
- Subjects with clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, neurological, sleep disorders by DSM-IV criteria, endocrine, hematological, or metabolic disease as determined by medical history and physical examination
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00903253
Start Date
May 1 2009
End Date
September 1 2009
Last Update
September 10 2009
Active Locations (1)
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1
CEDRA Clinical Research
Austin, Texas, United States, 78759