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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:
Information provided by:
Link Medicine Corporation
ClinicalTrials.gov Identifier:
NCT00903253
First received: May 14, 2009
Last updated: September 8, 2009
Last verified: September 2009
History of Changes
  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
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 May 23, 2013