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Protocol Summary for 114555

Protocol Summary
Protocol Id: 114555
Secondary Ids:
  • W0027-107
Title: A Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Tolerability And Pharmacokinetic Study Of Escalating Doses Of Albaconazole In Healthy Subjects
Phase: phase 1
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: No
Delayed Posting: No
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 73133
IND/IDE Serial Number: 0034
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
  • GSK
Brief Summary: The purpose of this study is to determine an upper dose of albaconzole to be administered in a Thorough QTc study.
Detailed Description: This study aims to evaluate the safety and tolerability of 5 days of albaconazole dosing at levels that exceed both the projected therapeutic dose and the projected therapeutic frequency, in order to identify an upper dose for administration in a TQTc study. It also aims to assess the pharmacokinetics of multiple escalating doses of albaconazole, and to assess the effects of multiple and sustained dosing of high doses of albaconazole on ECG parameters.
Record Verification Date: June 2012
Status: Completed
Why Study Stopped:
Study Start Date: August 2009
Study Completion Date: January 2010
Study Completion Date Type: Actual
Primary Completion Date: January 2010
Primary Completion Date Type: Actual
Primary Purpose: basic
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: yes
Masked Investigator: yes
Masked Assessor: yes
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Pharmacokinetics/dynamics Study
Primary Outcomes:
  • Plasma concentrations of albaconazole in subjects yes During 5 days of dosing and 15 days follow-up
Secondary Outcomes:
  • Electrocardiogram (ECG) QTc values yes During 5 days of dosing and 15 days follow-up
Conditions:
  • Onychomycosis
Keywords:
  • Pharmacokinetic
  • tolerability
  • multiple escalating doses
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 45 Year
Enrollment: 24
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information