Healthy Elderly Volunteers
Conditions
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
Interventions
DRUGLNK-754
Sponsors
Link Medicine Corporation
Study design
Allocation
RANDOMIZED
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Pharmacokinetics | 24 hours |
Countries
United States
Outcome results
None listed