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

NCT03070405 | Unknown Phase 1

• 1 other identifier: 16-0138
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Tenofovir Disoproxil Fumarate; 4-Aminosalicylic Acid; Tuberculosis; HIV

Outcome Measures

Primary Outcomes (2)

• Peak plasma concentration (Cmax) of tenofovir

  Cmax of Tenofovir will be compared between test and reference arms.

  0-84 hours in test and 0-72 hours in reference arm

• Area under the plasma concentration versus time curve (AUC) of tenofovir

  AUC of tenofovir will be compared between test and reference arms.

  0-84 hours in test and 0-72 hours in reference arm

Secondary Outcomes (12)

• Volume of distribution of tenofovir

  0-84 hours in test and 0-72 hours in reference arm

• Time of peak plasma concentration(Tmax) of tenofovir

  0-84 hours in test and 0-72 hours in reference arm

• Plasma half-life of tenofovir

  0-84 hours in test and 0-72 hours in reference arm

• Renal clearance of tenofovir

  0-24 hours

• Amount of tenofovir excreted in urine

  0-24 hours

Study Arms (2)

Tenofovir

ACTIVE COMPARATOR

Tenofovir disoproxil fumarate 300mg single dose administration

Drug: Tenofovir disoproxil fumarate 300mg

Tenofovir + PAS

EXPERIMENTAL

Tenofovir disoproxil fumarate 300mg single dose, Para-aminosalicylic acid Ca Granule 5.28 g BID seven dose administration

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

Interventions

Tenofovir disoproxil fumarate 300mg DRUG

Single oral dose on the first day of each period

Also known as: viread

Tenofovir; Tenofovir + PAS

Para-aminosalicylic acid Ca granule 5.28 g DRUG

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

Also known as: Pas Granule Dongindang

Tenofovir + PAS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Male participants included into the study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male volunteers, ages 19 to 45 years at the time of screening test inclusive.
• Subjects who did not have congenital or chronic diseases and sign and symptom after medical examinations
• Body Mass Index (BMI) of 18 to 25 kg/m2, inclusive. BMI = weight (kg)/ \[height (m)\]2.
• 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.
• Subjects who can participate in the whole clinical trial.
• 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.

You may not qualify if:

• Medical History
• 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.
• Subjects with any history of gastrointestinal diseases/conditions that could impact on the absorption of study drug.
• Laboratory Test and ECG Findings
• 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
• 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
• 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
• Subjects on any diet which could affected study drug's pharmacokinetics
• 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

Sponsors & Collaborators

• Inje University: lead

MeSH Terms

Conditions

Tuberculosis

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jae-Gook Shin, MD, PhD

  Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: March 3, 2017
• Study Start: October 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share