A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male Volunteers

A Phase I Single-Center, Randomized, Open-label, Single Dose, Crossover Study in Korean Healthy Male Volunteers to Evaluate Pharmacokinetics of Lozanoc and Sporanox

Study Objectives:

• To evaluate the pharmacokinetics (PK) of orally administered Lozanoc under fasted and fed condition in healthy male subjects
• To compare the pharmacokinetics (PK) of orally administered Lozanoc and Sporanox under fed condition in healthy male subjects
• To evaluate the safety and tolerability of single oral dose of Lozanoc and Sporanox in Korean healthy male subjects

Study Overview

• Status: Completed
• Conditions: Candidiasis; Dermatomycoses; Histoplasmosis; Superficial Mycoses
• Intervention / Treatment: Drug: Lozanoc 50mg; Drug: Sporanox 100mg

Detailed Description

Phase I Study divided into 3 parts written as bellows.

Part I. Lozanoc 50mg single dose under fed condition vs Part 2. Lozanoc 50mg single dose under fasted condition vs Part 3. Sporanox 100mg single dose under fed condition

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Korean male volunteers in the age between 19 and 50 years old (inclusive)
2. Subject who are able to give signed informed consent
3. Body mass index (BMI) in the range of 19 to 28 kg/m2 and weighting at least 50kg

4. Subject who are considered

   • Pre-study physical examination with no clinically significant abnormalities
   • No clinically significant medical history

   • Vital signs were to be within reference ranges, or if outside of the range, not deemed clinically significant in the opinion of the Investigator

     • 90 mmHg ≤ systolic blood pressure (sitting position) ≤ 140mmHg
     • 50 mmHg ≤ diastolic blood pressure (sitting position) ≤ 90 mmHg
   • Pre-study clinical laboratory findings were to be within reference range, or if outside of the range, not deemed clinically significant in the opinion of the Investigator
   • No clinically significant abnormalities in 12-lead ECG results

5. Agree to continue to use at least two accepted methods of birth control and not to donate sperm for at least 1 days before the first dosing, during the course of the study and for a period of 90days following the last dosing.

   • Acceptable methods of birth control are: female (sexual partner) hormonal contraceptives; intrauterine device; surgical sterility at least 6 months prior to screening (Ex. hysterectomy, bilateral oophorectomy, and/or tubal ligation); use diaphragm; use condom; or spermicide

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

1. History of allergy or sensitivity to any drug, including any prior serious adverse reaction to antifungal agent(s)
2. History of congestive heart failure or Patients with ventricular dysfunction such as congestive heart failure
3. Undergone surgery or who have a medical condition, that in the judgment of the Investigator, may affect absorption, distribution, metabolism or elimination of the drug product
4. Participated in a previous clinical trial within 90 days prior to screening visit
5. Donated blood or had a significant loss of blood within 60 days prior to screening visit
6. Special diet or substantial changes in eating habits within 30 days prior to screening visit
7. Use of any prescription medication within 14 days before screening visit
8. Use of any other OTC medication within the 7 days before screening visit
9. History of smoking within 3 months prior to screening visit
10. Have a recent history (within 2 years prior to the screening visit) of alcohol or drug abuse or a positive screen for drugs of abuse at screening
11. Positive blood screen for HIV or hepatitis B or C or syphilis
12. Clinically important abnormal hepatic function test (AST, ALT greater than 2 fold of reference upper limit (ULN), or total bilirubin greater than 1.5 x ULN)
13. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lozanoc 50mg; Lozanoc 50mg, oral administration	Drug: Lozanoc 50mg; Lozanoc 50mg single dose under fed and fasted condition
Active Comparator: Sporanox 100mg; Sporanox 100mg, oral administration	Drug: Sporanox 100mg; Sporanox 100mg single dose under fed condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax	0~120 hour after medication

Secondary Outcome Measures

Outcome Measure	Time Frame
tmax	0~120 hour after medication
AUCinf	0~120 hour after medication

Collaborators and Investigators

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Kyun-Seop Bae, M.D., Ph.D., Department of Clinical Pharmacology and Therapeutics, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Estimate): March 4, 2016
• Last Update Submitted That Met QC Criteria: March 3, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Candidiasis; Mycoses; Histoplasmosis; Dermatomycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: BR-ITR-CT-101