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.