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:
Information provided by:
Link Medicine Corporation
ClinicalTrials.gov Identifier:
NCT00903253
First received: May 14, 2009
Last updated: September 8, 2009
Last verified: September 2009
  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-Blind
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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903253

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

No publications provided

ClinicalTrials.gov Identifier: NCT00903253     History of Changes
Other Study ID Numbers: LNK754-0901-1A
Study First Received: May 14, 2009
Last Updated: September 8, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 18, 2014