Healthy VolunteersPhase 1NCT03070405
The Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects
A Phase 1 study testing Tenofovir disoproxil fumarate 300mg and Para-aminosalicylic acid Ca granule 5.28 g in people with Healthy Volunteers, run by Inje University.
Trial summary
The main purpose of this study is to evaluate whether PAS will change the PK parameters of tenofovir. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tenofovir disoproxil fumarate 300mg and Para-aminosalicylic acid Ca granule 5.28 g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to May 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
- 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.
- Blood transfusion within 30 days prior to study drug administration.
- Other Exclusion Criteria
- Alcohol over intake (alcohol > 30g/day) and screening positive for alcohol
- Subjects who smoke within 3 months before initiation of clinical trial and subjects who cannot stop smoking during the participation of clinical study
- 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
- Subjects deemed to be inappropriate for the trial as determined by the investigator.
About this study
Official title: An Open-label, Randomized, Crossover Study to Evaluate the Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects
The main purpose of this study is to evaluate whether PAS will change the PK parameters of tenofovir.
- Conditions
- Healthy Volunteers
- Being tested
- Tenofovir disoproxil fumarate 300mg, Para-aminosalicylic acid Ca granule 5.28 g
- Keywords
- Tenofovir Disoproxil Fumarate, 4-Aminosalicylic Acid, Tuberculosis, HIV
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxil fumarate 300mgDrug
Also called viread
Single oral dose on the first day of each period
Para-aminosalicylic acid Ca granule 5.28 gDrug
Also called Pas Granule Dongindang
Twice daily oral administration from the first day of each period to the seventh dose
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir | Active comparator | Tenofovir disoproxil fumarate 300mg single dose administration Receives: 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 Receives: Drug: Tenofovir disoproxil fumarate 300mg; Drug: Para-aminosalicylic acid Ca granule 5.28 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) of tenofovir
Cmax of Tenofovir will be compared between test and reference arms.
Measured: 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.
Measured: 0-84 hours in test and 0-72 hours in reference arm
Secondary outcomes (12)
Volume of distribution of tenofovir
Measured: 0-84 hours in test and 0-72 hours in reference arm
Time of peak plasma concentration(Tmax) of tenofovir
Measured: 0-84 hours in test and 0-72 hours in reference arm
Plasma half-life of tenofovir
Measured: 0-84 hours in test and 0-72 hours in reference arm
Renal clearance of tenofovir
Measured: 0-24 hours
Amount of tenofovir excreted in urine
Measured: 0-24 hours
Peak plasma concentration of PAS
Measured: 0-12 hours
Area under the plasma concentration versus time curve (AUC) of PAS
Measured: 0-12 hours
Renal clearance of PAS
Measured: 0-12 hours
Volume of distribution of PAS
Measured: 0-12 hours
Time of peak plasma concentration of PAS
Measured: 0-12 hours
Plasma half-life of PAS
Measured: 0-12 hours
Amount of PAS excreted in urine
Measured: 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startOct 2016
- Primary completionMar 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Gook Shin, Inje University
- Investigators
- Jae-Gook Shin, MD, PhD, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070405
- Sponsor's protocol ID
- 16-0138
- Status last verified
- Feb 2017
- First submitted
- 9 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Crossover Study to Evaluate the Effect of PAS on the Pharmacokinetics of Tenofovir in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03070405
- Acronym / sponsor ID
- 16-0138
- Conditions
- Healthy Volunteers
- Keywords
- Tenofovir Disoproxil Fumarate, 4-Aminosalicylic Acid, Tuberculosis, HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate whether PAS will change the PK parameters of tenofovir.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tenofovir | Active comparator | Drug: Tenofovir disoproxil fumarate 300mgTenofovir disoproxil fumarate 300mg single dose administration |
| Tenofovir + PAS | Experimental | Drug: Tenofovir disoproxil fumarate 300mg, Drug: Para-aminosalicylic acid Ca granule 5.28 gTenofovir disoproxil fumarate 300mg single dose, Para-aminosalicylic acid Ca Granule 5.28 g BID seven dose administration |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- Medical History
- Laboratory Test and ECG Findings
- 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
- Blood Donation and Transfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir disoproxil fumarate 300mgAlso: vireadSingle oral dose on the first day of each period | Drug | Tenofovir, Tenofovir + PAS |
| Para-aminosalicylic acid Ca granule 5.28 gAlso: Pas Granule DongindangTwice daily oral administration from the first day of each period to the seventh dose | Drug | Tenofovir + PAS |
Primary outcome
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.
12 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae-Gook Shin, MD, PhD principal investigator
Inje University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir disoproxil fumarate 300mg and Para-aminosalicylic acid Ca granule 5.28 g in people with Healthy Volunteers, run by Inje University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plasma concentration (Cmax) of tenofovir (time frame: 0-84 hours in test and 0-72 hours in reference arm). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.