Trial | NCT00903253  Report issue

Official Title

A Double-Blind, Placebo Controlled, Single, Escalating Dose Study to Evaluate the Preliminary Pharmacokinetics, Safety and Tolerability of LNK-754 in Healthy Elderly Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    lnk-754 ...

  • Study Participants

    40
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
Study Started
May 31
2009
Primary Completion
Sep 30
2009
Study Completion
Sep 30
2009
Last Update
Sep 10
2009
Estimate

Drug LNK-754

Criteria 

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
No Results Posted