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

NCT00903253 | Completed Phase 1 DMC

• 1 other identifier: LNK754-0901-1A
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Elderly Volunteers

Outcome Measures

Primary Outcomes (1)

• Plasma Pharmacokinetics

  24 hours

Interventions

LNK-754 DRUG

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Link Medicine Corporation: lead

Study Sites (1)

CEDRA Clinical Research

Austin, Texas, 78759, United States

Location

MeSH Terms

Interventions

LNK-754

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 18, 2009
• Study Start: May 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 10, 2009

Record last verified: 2009-09

Locations

US (1)