Protocol Summary for 114555
| Protocol Id: | 114555 |
| Secondary Ids: |
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| 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: |
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| 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: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion 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: |
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Click to view inclusion/exclusion criteria