Last updated: 11/03/2018 16:49:47
A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail Fungus
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled Tolerability And Pharmacokinetic Study Of Escalating Doses Of Albaconazole In Healthy Subjects
Trial description: The purpose of this study is to determine an upper dose of albaconzole to be administered in a Thorough QTc study.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Plasma concentrations of albaconazole in subjects
Timeframe: During 5 days of dosing and 15 days follow-up
Secondary outcomes:
Electrocardiogram (ECG) QTc values
Timeframe: During 5 days of dosing and 15 days follow-up
Interventions:
Enrollment:
24
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
onychomycosis
Product
albaconazole
Collaborators
GSK
Study date(s)
August 2009 to December 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 45 years
Accepts healthy volunteers
Yes
- Male or female subjects age 18 to 45
- A body mass index (BMI) between 18.5 and 30 kg/m2.
- 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.
Inclusion and exclusion 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. .
- 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.
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.
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.
Trial location(s)
Location
Spaulding Clinical Research, LLC
West Bend, Wisconsin, United States, 53095
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2009-04-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Results for study 114555 can be found on the GSK Clinical Study Register.
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