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A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail Fungus

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Albaconozole
Placebo
Albaconozole
Placebo
Albaconozole
Placebo
Sponsored by
Stiefel, a GSK Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Onychomycosis focused on measuring Pharmacokinetic, tolerability, multiple escalating doses

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or female subjects age 18 to 45
  • A body mass index (BMI) between 18.5 and 30 kg/m2.
  • Good physical and mental health.
  • Vital signs .within the acceptable range.
  • Electrocardiogram (12-lead) after at least 5 minutes in supine position considered as normal or with findings considered as not clinically significant by the investigator. .
  • Non-smoker for at least 6 months before screening.
  • Subject has screening laboratory parameters within the normal ranges unless considered to be not clinically relevant by the principal investigator. .
  • Subject is able to review and understand an informed consent, and must sign the independent ethics committee (IEC)/IRB approved informed consent form before any trial-related procedures are performed.

    • Sexually active females of childbearing potential must have a negative serum pregnancy test result at screening. These subjects must use a medically acceptable method of contraception while receiving protocol-assigned product, and are expected to continue to use this method of contraception for up to 90 days following the last dose of the study medication. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses.

Women who are not currently sexually active or lactating must agree to use 2 forms of nonhormonal contraception, should they become sexually active while participating in the study, and for 90 days following the end of participation in the study. Male subjects and/or their partners must use a medically acceptable form of contraception while receiving protocol-assigned product, and up to 90 days following the last dose of the study medication.

  • Subject is willing and able to take the assigned clinical trial medication as directed, comply with clinical trial instructions, and commit to all study visits.

Exclusion Criteria:

  • History of intolerance to any of the ingredients in the study medications, or other related drugs, or history of relevant/clinically significant allergic reactions of any origin.
  • Any disease or physical condition that, in the opinion of the investigator, could impact the PK/pharmacodynamics of the drug or could potentially compromise the safety of the subject.
  • Subject has previously participated in a clinical study of albaconazole.
  • History of drug, prescription medicine, or alcohol abuse within the past 2 years.
  • Positive drug screen.
  • History of psychological or other emotional problems that are likely to invalidate informed consent, or could limit the ability of the subject to comply with the protocol requirements.
  • Any drug treatment taken within 14 days before the first drug intake or within 5 half-lives whichever is longer.
  • Participation in another clinical trial, blood donation, or significant blood loss less than 30 days before the first intake of study drug.
  • Unsuitable veins for repeated venipuncture.
  • Subject has any known liver disease or liver toxicity with other drugs.
  • Subject has a predose ECG before dosing with a QTcB or QTcF interval >450 msec, or abnormal morphology of the ECG, or clinically serious arrhythmia.
  • Subjects who are pregnant, breast-feeding, women of childbearing potential not using adequate contraceptives or planning to conceive, or male subjects who plan to father a child as described in the informed consent.
  • Positive for hepatitis B (HBsAg) or hepatitis C (Ab HCV) or HIV or AIDS.
  • Consumption of any excluded drugs or foodstuff within 72 hours before dosing.
  • Subjects who are employees of a clinical research organization involved in the study, or Stiefel, or an immediate family member.
  • Subjects who have a member of the same household in this study.

Sites / Locations

  • Spaulding Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Albaconazole 400 mg cohort 1

Placebo cohort 1

Albaconozole 400 mg cohort 2

Placebo cohort 2

Albaconozole 400 mg cohort 3

Placebo cohort 3

Arm Description

Albaconazole 400 mg

Placebo once daily

Albaconozole 400 mg every 12 hours

Placebo every 12 hours

Albaconozole 400 mg every 8 hours

Placebo every 8 hours

Outcomes

Primary Outcome Measures

Plasma concentrations of albaconazole in subjects

Secondary Outcome Measures

Electrocardiogram (ECG) QTc values

Full Information

First Posted
November 16, 2009
Last Updated
June 19, 2017
Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01014962
Brief Title
A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail Fungus
Official Title
A Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Tolerability And Pharmacokinetic Study Of Escalating Doses Of Albaconazole In Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 24, 2009 (Actual)
Primary Completion Date
December 4, 2009 (Actual)
Study Completion Date
December 4, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stiefel, a GSK Company
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis
Keywords
Pharmacokinetic, tolerability, multiple escalating doses

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albaconazole 400 mg cohort 1
Arm Type
Experimental
Arm Description
Albaconazole 400 mg
Arm Title
Placebo cohort 1
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Arm Title
Albaconozole 400 mg cohort 2
Arm Type
Experimental
Arm Description
Albaconozole 400 mg every 12 hours
Arm Title
Placebo cohort 2
Arm Type
Placebo Comparator
Arm Description
Placebo every 12 hours
Arm Title
Albaconozole 400 mg cohort 3
Arm Type
Experimental
Arm Description
Albaconozole 400 mg every 8 hours
Arm Title
Placebo cohort 3
Arm Type
Placebo Comparator
Arm Description
Placebo every 8 hours
Intervention Type
Drug
Intervention Name(s)
Albaconozole
Intervention Description
Albaconozole 400 mg oral once daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral once daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Albaconozole
Intervention Description
Albaconozole 400 mg every 12 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral every 12 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
Albaconozole
Intervention Description
Albaconozole 400 mg oral every 8 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral every 8 hours for 5 days
Primary Outcome Measure Information:
Title
Plasma concentrations of albaconazole in subjects
Time Frame
During 5 days of dosing and 15 days follow-up
Secondary Outcome Measure Information:
Title
Electrocardiogram (ECG) QTc values
Time Frame
During 5 days of dosing and 15 days follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female subjects age 18 to 45 A body mass index (BMI) between 18.5 and 30 kg/m2. Good physical and mental health. Vital signs .within the acceptable range. Electrocardiogram (12-lead) after at least 5 minutes in supine position considered as normal or with findings considered as not clinically significant by the investigator. . Non-smoker for at least 6 months before screening. Subject has screening laboratory parameters within the normal ranges unless considered to be not clinically relevant by the principal investigator. . Subject is able to review and understand an informed consent, and must sign the independent ethics committee (IEC)/IRB approved informed consent form before any trial-related procedures are performed. Sexually active females of childbearing potential must have a negative serum pregnancy test result at screening. These subjects must use a medically acceptable method of contraception while receiving protocol-assigned product, and are expected to continue to use this method of contraception for up to 90 days following the last dose of the study medication. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Women who are not currently sexually active or lactating must agree to use 2 forms of nonhormonal contraception, should they become sexually active while participating in the study, and for 90 days following the end of participation in the study. Male subjects and/or their partners must use a medically acceptable form of contraception while receiving protocol-assigned product, and up to 90 days following the last dose of the study medication. Subject is willing and able to take the assigned clinical trial medication as directed, comply with clinical trial instructions, and commit to all study visits. Exclusion Criteria: History of intolerance to any of the ingredients in the study medications, or other related drugs, or history of relevant/clinically significant allergic reactions of any origin. Any disease or physical condition that, in the opinion of the investigator, could impact the PK/pharmacodynamics of the drug or could potentially compromise the safety of the subject. Subject has previously participated in a clinical study of albaconazole. History of drug, prescription medicine, or alcohol abuse within the past 2 years. Positive drug screen. History of psychological or other emotional problems that are likely to invalidate informed consent, or could limit the ability of the subject to comply with the protocol requirements. Any drug treatment taken within 14 days before the first drug intake or within 5 half-lives whichever is longer. Participation in another clinical trial, blood donation, or significant blood loss less than 30 days before the first intake of study drug. Unsuitable veins for repeated venipuncture. Subject has any known liver disease or liver toxicity with other drugs. Subject has a predose ECG before dosing with a QTcB or QTcF interval >450 msec, or abnormal morphology of the ECG, or clinically serious arrhythmia. Subjects who are pregnant, breast-feeding, women of childbearing potential not using adequate contraceptives or planning to conceive, or male subjects who plan to father a child as described in the informed consent. Positive for hepatitis B (HBsAg) or hepatitis C (Ab HCV) or HIV or AIDS. Consumption of any excluded drugs or foodstuff within 72 hours before dosing. Subjects who are employees of a clinical research organization involved in the study, or Stiefel, or an immediate family member. Subjects who have a member of the same household in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Spaulding Clinical Research, LLC
City
West Bend
State/Province
Wisconsin
ZIP/Postal Code
53095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail Fungus

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