NCT02122939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2013

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
Last Updated

June 3, 2014

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

April 23, 2014

Last Update Submit

May 30, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Cmax, AUCinf, AUClast, Tmax, t1/2, CL/F

    pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 32, 48 h post-dose

Secondary Outcomes (1)

  • QTc interval

    pre-dose, 1, 4, 6, 8, 12, 24, 28, 32, 48 h post-dose

Study Arms (1)

Escitalopram

EXPERIMENTAL
Drug: Escitalopram

Interventions

EscitalopramDRUG
Escitalopram

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Gyounggi, South Korea

Location

MeSH Terms

Interventions

Escitalopram

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jae-Yong Chung, MD, PhD

    Seoul National University Bundang Hospital, Seongnam, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 23, 2014

First Posted

April 25, 2014

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

June 3, 2014

Record last verified: 2014-05

Locations

KR(1)