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OpenTrials
Completed

NCT Number: NCT00903253

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

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

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CEDRA Clinical Research

Austin, Texas, 78759, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LNK-754

Drug

Primary outcomes

  1. Plasma Pharmacokinetics

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Link Medicine Corporation

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 18, 2009
Registry last updated
Sep 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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