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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

Tracking Information
First Submitted Date  ICMJE July 7, 2015
First Posted Date  ICMJE July 9, 2015
Last Update Posted Date March 4, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
Cmax [ Time Frame: 0~120 hour after medication ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02493738 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2015)
  • tmax [ Time Frame: 0~120 hour after medication ]
  • AUCinf [ Time Frame: 0~120 hour after medication ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate the Pharmacokinetics of Lozanoc and Sporanox in Korean Healthy Male Volunteers
Official Title  ICMJE A Phase I Single-Center, Randomized, Open-label, Single Dose, Crossover Study in Korean Healthy Male Volunteers to Evaluate Pharmacokinetics of Lozanoc and Sporanox
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
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Superficial Mycoses
  • Dermatomycoses
  • Candidiasis
  • Histoplasmosis
Intervention  ICMJE
  • Drug: Lozanoc 50mg
    Lozanoc 50mg single dose under fed and fasted condition
  • Drug: Sporanox 100mg
    Sporanox 100mg single dose under fed condition
Study Arms  ICMJE
  • Experimental: Lozanoc 50mg
    Lozanoc 50mg, oral administration
    Intervention: Drug: Lozanoc 50mg
  • Active Comparator: Sporanox 100mg
    Sporanox 100mg, oral administration
    Intervention: Drug: Sporanox 100mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02493738
Other Study ID Numbers  ICMJE BR-ITR-CT-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boryung Pharmaceutical Co., Ltd
Study Sponsor  ICMJE Boryung Pharmaceutical Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kyun-Seop Bae, M.D., Ph.D. Department of Clinical Pharmacology and Therapeutics, Asan Medical Center
PRS Account Boryung Pharmaceutical Co., Ltd
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP