A Study to Compare the Blood Levels of Albaconazole in Healthy Subjects Who Have Received a Single Dose of 400 mg Albaconazole as a Tablet Versus Albaconazole as a Capsule

NCT01039883 | Completed Phase 1

• 1 other identifier: 114563
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether albaconazole tablets and albaconazole capsules (single 400mg dose) act in the body in the same way over a period of time.

Conditions

Onychomycosis

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Bioavailability of albaconazole

  Blood samples taken predose and at 30 minutes, and 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 (day 1 time points), 18 (day 2), 24 (day 2), hours post-dose and once a day on days 3-16

Secondary Outcomes (1)

• Safety and tolerability of a single oral dose of 400mg albaconazole tablet

  ECGs and lab tests at screening, pre-dose, and 3 hours, and 16 days post-dose. Physical examination at screening, pre-dose and 16 days post-dose. Assessment of adverse events from consent to 16 days post-dose (second dosing period).

Study Arms (2)

1

EXPERIMENTAL

Subjects randomized to study product sequence 1 will receive the single albaconazole 400-mg tablet during the first dosing period and the four 100-mg albaconazole capsules during the second dosing period.

Drug: Albaconazole tablet 400mg

2

EXPERIMENTAL

Subjects randomized to study product sequence 2 will receive the four 100-mg albaconazole capsules during the first dosing period and the single albaconazole 400-mg tablet during the second dosing period.

Drug: Albaconazole 100mg capsules, then albaconazole 400mg tablet

Interventions

Albaconazole tablet 400mg DRUG

Albaconazole tablet 400mg single dose, then four albaconazole capsule 100mg single dose

Also known as: Albaconazole

1

Albaconazole 100mg capsules, then albaconazole 400mg tablet DRUG

Four albaconazole capsule 100mg single dose, then albaconazole tablet 400mg single dose

Also known as: Albaconazole

2

Eligibility Criteria

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

You may qualify if:

• Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
• Male or female aged from 18 to 45 years at time of consent and at time of first dose.
• A body mass index (BMI) between 18.5 and 30 kg/m2.
• Able to complete the study and to comply with study instructions.
• Free of clinically significant disease as determined by history, physical examination, and laboratory testing.
• The subject is a non-smoker or ex-smoker. If a subject is an ex smoker, he/she must not have used nicotine for at least 6 months before first dose.
• The screening and baseline laboratory parameters must be within normal ranges unless agreed as not clinically relevant by the principal investigator and the sponsor. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin values should be lower than 1.5 times the upper normal limit at screening.
• The subject will have negative results for the following tests at screening:
• Hepatitis B surface antigen (HBsAg)
• Hepatitis B core antibodies (HBcAc)
• Anti-hepatitis C virus (Anti-HCV)
• Human immunodeficiency virus (HIV) antibody test
• Urine drug screen
• Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and until 30 days following the last dose of the study product. 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. Acceptable contraceptive methods include the following:
• Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed.

You may not qualify if:

• Female who is pregnant (positive pregnancy test), trying to become pregnant, or breast feeding.
• Received any investigational drug within 30 days of study day 1 or who are scheduled to receive an investigational drug other than the study product during the study.
• Used prescription drug therapy, over the counter (nonprescription) medications, recreational drugs, or herbal products within 30 days of dosing, unless agreed as not clinically relevant by the principal investigator and sponsor.
• Participated in a previous study of the same study product.
• Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
• Currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
• Has a history of anemia, iron deficiency, or iron depletion.
• Has a history of any condition possibly affecting absorption of drug (eg, peptic ulcer disease, gastrectomy, intestinal malabsorption).
• Considered immunocompromised.
• History of drug, prescription medicine, or alcohol abuse within the past 2 years.
• Has a history of known or suspected intolerance to any of the ingredients of the study products.
• Has known drug allergies.
• Has a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
• Intends to donate blood or blood components while receiving the study product or for the duration of the pharmacokinetic sampling period.
• Has donated blood or has had significant blood loss (≥250 mL) within 30 days before dosing or has donated plasma within 7 days before dosing.

Sponsors & Collaborators

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

Study Sites (1)

Buffalo Clinical Research Center

Buffalo, New York, 14202, United States

Location

Related Publications (1)

• van Rossem K, Lowe JA. A Phase 1, randomized, open-label crossover study to evaluate the safety and pharmacokinetics of 400 mg albaconazole administered to healthy participants as a tablet formulation versus a capsule formulation. Clin Pharmacol. 2013;5:23-31. doi: 10.2147/CPAA.S39600. Epub 2013 Jan 30.

  PMID: 23390369 BACKGROUND

Related Links

• Results for study 114563 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Onychomycosis

Interventions

albaconazole; Capsules; Tablets

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 25, 2009
• Study Start: November 23, 2009
• Primary Completion: January 20, 2010
• Study Completion: January 20, 2010
• Last Updated: June 22, 2017

Record last verified: 2017-06

Locations

US (1)