Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02493738
Recruitment Status : Completed
First Posted : July 9, 2015
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Boryung Pharmaceutical Co., Ltd

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Superficial Mycoses Dermatomycoses Candidiasis Histoplasmosis Drug: Lozanoc 50mg Drug: Sporanox 100mg Phase 1

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: 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 Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Cmax [ Time Frame: 0~120 hour after medication ]

Secondary Outcome Measures :
  1. tmax [ Time Frame: 0~120 hour after medication ]
  2. AUCinf [ Time Frame: 0~120 hour after medication ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02493738


Locations
Layout table for location information
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Investigators
Layout table for investigator information
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Department of Clinical Pharmacology and Therapeutics, Asan Medical Center

Layout table for additonal information
Responsible Party: Boryung Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02493738     History of Changes
Other Study ID Numbers: BR-ITR-CT-101
First Posted: July 9, 2015    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Layout table for MeSH terms
Mycoses
Candidiasis
Histoplasmosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Skin Diseases
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors