Clinical Trials

MainTitle

The Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects

This study is ongoing, but not recruiting participants.
Sponsor
Inje University


Information provided by (Responsible Party)
Jae-Gook Shin, Inje University

ClinicalTrials.gov Identifier
NCT03070405

First received: February 9, 2017
Last updated: March 2, 2017
Last Verified: February 2017
History of Changes
Purpose

Purpose

The main purpose of this study is to evaluate whether PAS will change the PK parameters of tenofovir.

Condition Intervention Phase
Healthy Volunteers

Drug : Tenofovir disoproxil fumarate 300mg
Drug : Para-aminosalicylic acid Ca granule 5.28 g
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: An Open-label, Randomized, Crossover Study to Evaluate the Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects

Further study details as provided by Jae-Gook Shin, Inje University:

Primary Outcome Measures

  • Peak plasma concentration (Cmax) of tenofovir [ Time Frame: 0-84 hours in test and 0-72 hours in reference arm ]
    Cmax of Tenofovir will be compared between test and reference arms.
  • Area under the plasma concentration versus time curve (AUC) of tenofovir [ Time Frame: 0-84 hours in test and 0-72 hours in reference arm ]
    AUC of tenofovir will be compared between test and reference arms.
Secondary Outcome Measures:
  • Volume of distribution of tenofovir [ Time Frame: 0-84 hours in test and 0-72 hours in reference arm ]
  • Time of peak plasma concentration(Tmax) of tenofovir [ Time Frame: 0-84 hours in test and 0-72 hours in reference arm ]
  • Plasma half-life of tenofovir [ Time Frame: 0-84 hours in test and 0-72 hours in reference arm ]
  • Renal clearance of tenofovir [ Time Frame: 0-24 hours ]
  • Amount of tenofovir excreted in urine [ Time Frame: 0-24 hours ]
  • Peak plasma concentration of PAS [ Time Frame: 0-12 hours ]
  • Area under the plasma concentration versus time curve (AUC) of PAS [ Time Frame: 0-12 hours ]
  • Renal clearance of PAS [ Time Frame: 0-12 hours ]
  • Volume of distribution of PAS [ Time Frame: 0-12 hours ]
  • Time of peak plasma concentration of PAS [ Time Frame: 0-12 hours ]
  • Plasma half-life of PAS [ Time Frame: 0-12 hours ]
  • Amount of PAS excreted in urine [ Time Frame: 0-12 hours ]

Estimated Enrollment: 20
Study Start Date: October 2016
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Tenofovir
Tenofovir disoproxil fumarate 300mg single dose administration
Drug: Tenofovir disoproxil fumarate 300mg

Single oral dose on the first day of each period

Other Name: viread
Experimental: Tenofovir + PAS
Tenofovir disoproxil fumarate 300mg single dose, Para-aminosalicylic acid Ca Granule 5.28 g BID seven dose administration
Drug: Tenofovir disoproxil fumarate 300mg

Single oral dose on the first day of each period

Other Name: viread
Drug: Para-aminosalicylic acid Ca granule 5.28 g

Twice daily oral administration from the first day of each period to the seventh dose

Other Name: Pas Granule Dongindang
Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 45 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

Criteria

Inclusion Criteria:

  1. Healthy adult male volunteers, ages 19 to 45 years at the time of screening test inclusive.
  2. Subjects who did not have congenital or chronic diseases and sign and symptom after medical examinations
  3. Body Mass Index (BMI) of 18 to 25 kg/m2, inclusive. BMI = weight (kg)/ [height (m)]2.
  4. Volunteers deemed as appropriate subjects by investigators, after passing medical screening, including assessment of medical history, vital signs, 12-lead ECG, physical examination, laboratory tests etc. according to the characteristics of the investigational products.
  5. Subjects who can participate in the whole clinical trial.
  6. Subjects who voluntarily sign a written consent form after having received information regarding the objectives and contents of the trial, and characteristics of the study drug drugs prior to signing.

  • Exclusion Criteria:
  • Medical History
    1. Subjects with any disease or history of clinically significant liver, kidney, digestive system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatric system, hemato-oncologic system, urinary system, cardiovascular system including arrhythmia.
    2. Subjects with any history of gastrointestinal diseases/conditions that could impact on the absorption of study drug.
  • Laboratory Test and ECG Findings
    1. Subjects who show, or have had clinical abnormalities detected through laboratory tests prior to the trial commencement date. Criteria for liver and renal function test are shown below:
  • AST or ALT above 1.25×ULN
  • Total bilirubin above 1.5×ULN
  • Serum creatinine clearance calculated by CKD-EPI below 80mL/min ~#o2~ Subjects who show a clinically significant abnormalities detected through ECG
  • History of hypersensitivity to the drug including study drug ingredients and other medications (aspirin, antibiotics, etc.) or clinically significant hypersensitivity
  • Prohibition on Concomitant Drug/Food
    1. Use of ethical-the-counter/herbal preparations or use of over-the-counter medications/vitamin medications within 2 weeks or 1 week prior to study drug administration, respectively
    2. Subjects on any diet which could affected study drug's pharmacokinetics
    3. Subjects who administered the Probenecid, Penicillin G and other drugs which already known has an effect on OAT1 Transporter activity within 2 weeks prior to the first dose.
  • Blood Donation and Transfusion
    1. Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 60 days prior to study drug administration.
    2. Blood transfusion within 30 days prior to study drug administration.
  • Other Exclusion Criteria
    1. Alcohol over intake (alcohol > 30g/day) and screening positive for alcohol
    2. Subjects who smoke within 3 months before initiation of clinical trial and subjects who cannot stop smoking during the participation of clinical study
    3. Subjects who cannot stop taking caffeine-containing foods (e.g. coffee, tea, green tea, cocoa, chocolate, soda, coffee milk, energy supplementary beverage, etc.) and alcoholic beverage during the participation of clinical study
    4. Subjects deemed to be inappropriate for the trial as determined by the
    investigator.

    contacts and locations

    Contacts and Locations

    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, see Learn About Clinical Studies.

    Please refer to this study by its ClinicalTrials.gov identifier: NCT03070405

    Sponsors and Collaborators

    Inje University

    Investigators

    Principal Investigator: Jae-Gook Shin, MD, PhD Inje University
    More Information

    More Information


    Responsible Party: Jae-Gook Shin, Principal Investigator, Inje University  
    ClinicalTrials.gov Identifier: NCT03070405   History of Changes  
    Other Study ID Numbers: 16-0138  
    Study First Received: February 9, 2017  
    Last Updated: March 2, 2017  
    Individual Participant Data    
    Plan to Share IPD: No  

    Keywords provided by Jae-Gook Shin, Inje University:

    Tenofovir Disoproxil Fumarate
    4-Aminosalicylic Acid
    Tuberculosis
    HIV

    Additional relevant MeSH terms:
    Tenofovir
    Aminosalicylic Acid

    ClinicalTrials.gov processed this data on December 08, 2017
    This information is provided by ClinicalTrials.gov.