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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00903253
First Posted: May 18, 2009
Last Update Posted: September 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Link Medicine Corporation
  Purpose
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

Condition Intervention Phase
Healthy Elderly Volunteers Drug: LNK-754 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
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

Further study details as provided by Link Medicine Corporation:

Primary Outcome Measures:
  • Plasma Pharmacokinetics [ Time Frame: 24 hours ]

Estimated Enrollment: 40
Study Start Date: May 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00903253


Locations
United States, Texas
CEDRA Clinical Research
Austin, Texas, United States, 78759
Sponsors and Collaborators
Link Medicine Corporation
  More Information

ClinicalTrials.gov Identifier: NCT00903253     History of Changes
Other Study ID Numbers: LNK754-0901-1A
First Submitted: May 14, 2009
First Posted: May 18, 2009
Last Update Posted: September 10, 2009
Last Verified: September 2009