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

Healthy Volunteers Clinical Trial

Official title:

An Open-label, Randomized, Crossover Study to Evaluate the Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03070405
• Other study ID #: 16-0138
• Status: Active, not recruiting
• Phase: Phase 1
• First received: February 9, 2017
• Last updated: March 2, 2017
• Start date: October 2016
• Est. completion date: May 2017

Study information

• Verified date: February 2017
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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:

1. 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.

2. 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

2. Subjects who show a clinically significant abnormalities detected through ECG

3. History of hypersensitivity to the drug including study drug ingredients and other medications (aspirin, antibiotics, etc.) or clinically significant hypersensitivity

4. 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.

5. 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.

6. 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Tenofovir disoproxil fumarate 300mg
Single oral dose on the first day of each period
• Para-aminosalicylic acid Ca granule 5.28 g
Twice daily oral administration from the first day of each period to the seventh dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Volume of distribution of tenofovir		0-84 hours in test and 0-72 hours in reference arm
Secondary	Time of peak plasma concentration(Tmax) of tenofovir		0-84 hours in test and 0-72 hours in reference arm
Secondary	Plasma half-life of tenofovir		0-84 hours in test and 0-72 hours in reference arm
Secondary	Renal clearance of tenofovir		0-24 hours
Secondary	Amount of tenofovir excreted in urine		0-24 hours
Secondary	Peak plasma concentration of PAS		0-12 hours
Secondary	Area under the plasma concentration versus time curve (AUC) of PAS		0-12 hours
Secondary	Renal clearance of PAS		0-12 hours
Secondary	Volume of distribution of PAS		0-12 hours
Secondary	Time of peak plasma concentration of PAS		0-12 hours
Secondary	Plasma half-life of PAS		0-12 hours
Secondary	Amount of PAS excreted in urine		0-12 hours