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

Healthy Elderly Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00903253
• Other study ID #: LNK754-0901-1A
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2009
• Last updated: September 8, 2009
• Start date: May 2009
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Link Medicine Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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

Allocation: Randomized, Masking: Double-Blind

Related Conditions & MeSH terms

• Healthy Elderly Volunteers

Intervention

Drug:
• LNK-754

Locations

Country	Name	City	State
United States	CEDRA Clinical Research	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Link Medicine Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Pharmacokinetics		24 hours	Yes