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

NCT01014962 | Completed Phase 1

• 1 other identifier: 114555
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine an upper dose of albaconzole to be administered in a Thorough QTc study.

Conditions

Onychomycosis

Keywords

Pharmacokinetic; tolerability; multiple escalating doses

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of albaconazole in subjects

  During 5 days of dosing and 15 days follow-up

Secondary Outcomes (1)

• Electrocardiogram (ECG) QTc values

  During 5 days of dosing and 15 days follow-up

Study Arms (6)

Albaconazole 400 mg cohort 1

EXPERIMENTAL

Albaconazole 400 mg

Drug: Albaconozole

Placebo cohort 1

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Albaconozole 400 mg cohort 2

EXPERIMENTAL

Albaconozole 400 mg every 12 hours

Drug: Albaconozole

Placebo cohort 2

PLACEBO COMPARATOR

Placebo every 12 hours

Drug: Placebo

Albaconozole 400 mg cohort 3

EXPERIMENTAL

Albaconozole 400 mg every 8 hours

Drug: Albaconozole

Placebo cohort 3

PLACEBO COMPARATOR

Placebo every 8 hours

Drug: Placebo

Interventions

Albaconozole DRUG

Albaconozole 400 mg oral once daily for 5 days

Albaconazole 400 mg cohort 1

Placebo DRUG

Placebo oral once daily for 5 days

Placebo cohort 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Spaulding Clinical Research, LLC

West Bend, Wisconsin, 53095, United States

Location

Related Links

• Results for study 114555 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: August 24, 2009
• Primary Completion: December 4, 2009
• Study Completion: December 4, 2009
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

US (1)