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

NCT ID: NCT00903253

Last Updated: 2009-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Healthy Elderly Volunteers

Study Design

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Allocation Method

RANDOMIZED

Blinding Strategy

DOUBLE

Interventions

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LNK-754

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Link Medicine Corporation

INDUSTRY

Sponsor Role lead

Locations

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CEDRA Clinical Research

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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LNK754-0901-1A

Identifier Type: -

Identifier Source: org_study_id

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