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

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Status and phase: Completed; Phase 1

Conditions: Healthy Elderly Volunteers

Treatments: Drug: LNK-754

Study type: Interventional

Funder types: Industry

Identifiers

NCT00903253

LNK754-0901-1A

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

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