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

Phase 1

Completed

• Conditions: Healthy Elderly Volunteers

• Registration Number: NCT00903253
• Lead Sponsor: Link Medicine Corporation

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-18
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-08
• Last Update Posted: 2009-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma Pharmacokinetics	24 hours

Trial Locations

Locations (1)

CEDRA Clinical Research; 🇺🇸 Austin, Texas, United States