Overview

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

Status:
Completed
Trial end date:
2009-12-04
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine an upper dose of albaconzole to be administered in a Thorough QTc study.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Stiefel, a GSK Company
Collaborator:
GlaxoSmithKline
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.