A Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram in Elderly Volunteers

• ClinicalTrials.gov Identifier: NCT02122939
• Recruitment Status: Completed
• First Posted: April 25, 2014
• Last Update Posted: June 3, 2014
• Sponsor: Seoul National University Hospital
• Information provided by (Responsible Party): Jae Yong Chung, Seoul National University Bundang Hospital

Tracking Information

• First Submitted Date: April 23, 2014
• First Posted Date: April 25, 2014
• Last Update Posted Date: June 3, 2014
• Study Start Date: September 2013
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 24, 2014): Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F [ Time Frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 32, 48 h post-dose ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02122939 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: April 24, 2014): QTc interval [ Time Frame: pre-dose, 1, 4, 6, 8, 12, 24, 28, 32, 48 h post-dose ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram in Elderly Volunteers
• Official Title: An Open-label, Single Dosing Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram After Oral Administration in Elderly Volunteers
• Brief Summary: An Open-label, single dosing clinical trial to investigate the pharmacokinetics and the effect on ECG of escitalopram after oral administration in elderly volunteers.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy
• Intervention: Drug: Escitalopram

Study Arms

Experimental: Escitalopram

Intervention: Drug: Escitalopram

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 30, 2014): 12
• Original Enrollment: Not Provided
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• healthy subject aged 65 or older at screening
• A body weight in the range of 50 kg (inclusive) to 90 kg (inclusive) with BMI range of 19.0 to 28.0
• subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

• subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
• Subject judged not eligible for study participation by investigator

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02122939
• Other Study ID Numbers: ECTE
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jae Yong Chung, Seoul National University Bundang Hospital
• Study Sponsor: Seoul National University Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jae-Yong Chung, MD, PhD; Seoul National University Bundang Hospital, Seongnam, Korea

• PRS Account: Seoul National University Hospital
• Verification Date: May 2014