AzTrials
AzTrials

Food EffectPhase 4NCT03885778

A Food Effect Study of Besifovir in Healthy Subjects

A Phase 4 study testing Besifovir dipivoxil in people with Food Effect and Health Subjects, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To investigate the PK characteristics and the effect of food on the PK in healthy volunteers who receive Besifovir dipivoxil in fed versus fasted condition Read more about this study

Who is it for?
Ages 19 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Food Effect, Health Subjects
What is being tested?
Besifovir dipivoxil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSouth Korea
Study dates
13 Jan 2019to 12 Feb 2019
Phase
Phase 4
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 19 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
  • Age of 19 to 50 years and Body Mass Index [BMI] of 18.0 to 27.0 kg/m2
  • Subject with no congenital or chronic disease and no medically symptomatic findings
  • Subject must be healthy on the basis of vital signs, 12-lead ECG, physical examination and laboratory test performed at screening.

Who cannot join

  • Medical history
  • History of clinically significant of gastrointestinal system, hepatic portal system, cardiovascular system, respiratory system, endocrine system, renal-urinary system, immunologic system, musculoskeletal system, neurological, or psychiatric system, blood tumor, ophthalmology, otolaryngology disorder(as determined by the Investigator).
  • Prior history of a gastrointestinal disorder that may affect drug absorption, distribution, metabolism and elimination (e.g., Crohn's disease, ulcer or surgery, except for simple appendectomy or hernia surgery)
  • Clinical tests
  • Systolic Blood Pressure: lower than 90mmHg or higher than 140mmHg, Diastolic Blood Pressure: lower than 60mmHg or higher than 180mmHg
  • Repeated measurement of laboratory value outside the reference range that the investigator considers to be of clinical relevance
Show all 35Show fewer
  • Aspartate transaminase [AST] or alanine aminotransferase [ALT] > 1.5 x upper limit of normal range
  • Total bilirubin > 1.5 x upper limit of normal range
  • estimated glomerular filtration rate [eGFR] < 75mL/min/1.73m2 (using Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equations)
  • Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV), anti-Human immunodeficiency virus(HIV) or Syphilis reagin test
  • Subjects with clinically significant abnormalities in 12-lead ECG determined by repeated measurement
  • Allergy, hypersensitivity, and drug abuse
  • History of significant hypersensitivity to Besifovir, this drug ingredient or other drug (e.g., aspirin, antibiotics)
  • History of clinically significant allergy/hypersensitivity
  • A history of drug abuse (especially, central nervous system agents such as sleeping pills, central painkillers, opiates or psychotropic drugs) or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs(amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines)
  • The contraindication of comedication drugs and diets
  • Subject who has taken drugs for drug metabolizing enzyme induction and inhibition within 1 month before the first adminstration
  • Subject who has taken other ethical the count [ETC] drugs (including prescription of herbal medicine) within the last 14 days, or over the count [OTC] drugs within the last 10 days (as determined by the Investigators)
  • Subject who has taken abnormal meals (eg. ingestion of grapefruit juice, garlic extract, broccoli, and kale) which can affect to drug absorption, distribution, metabolism, and excretion [ADME] and supplements within 7 days prior to administration of trial medication and during the trial
  • Subject who has participated in any other bioequivalence study or clinical trial and taken other investigational products within 3 months prior to the first adminstration
  • Donation and receipt of blood
  • Subject who had whole blood donation within 2 months prior to administration of trial medication
  • Subject who had component blood donation or transfusion within 1 months prior to administration of trial medication
  • Pregnant and contraception
  • Pregnant, positive of pregnancy test or breast-feeding women
  • Subjects who do not use medically acceptable contraception during the entire period of the trial
  • Use of intrauterine device
  • Use of intercourse contraceptive (male or female) and spermicide
  • Vasectomy
  • Tubectomy, canal ligation and hysterectomy
  • Other criteria
  • Use of Xanthine (eg. green tea, coffee, black tea, coke, cocoa, chocolate, energy drink, and etc.) within 3 days prior to administration of trial medication and during the trial
  • Intake of more than 30g of alcohol per day or who can't abstain from alcohol during the trial
  • Subjects who can't quit smoking during the trial
  • Subjects who are considered to be unacceptable in this study under the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Inje University Busan Paik Hospital

    Busan

Other trials in South Korea

About this study

Official title: An Open Label, Randomized, 2-sequence, 2-period, Single-dose Cross-over Design Clinical Trial to Evaluate the Food Effect on Pharmacokinetics of BESIVO in Healthy Adult Volunteers

To investigate the PK characteristics and the effect of food on the PK in healthy volunteers who receive Besifovir dipivoxil in fed versus fasted condition

Read the detailed description

A randomized, open-label, 2-sequence, 2-period, single-dose cross-over clinical trial to investigate the pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of Besifovir dipivoxil in healthy volunteers

Being tested
Besifovir dipivoxil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Besifovir dipivoxilDrug

    Also called Besivo tab

    150mg Besifovir dipivoxil, single dose, oral

Study groups in NCT03885778
Study groupRoleWhat they receive
A-fasted dosing followed by fed dosingExperimentalFasted dosing of Besifovir dipivoxil followed by fed dosing; Dosing in the fasted state followed by fed dosing
Receives: Drug: Besifovir dipivoxil
B-fed dosing followed by fasted dosingExperimentalFed dosing of Besifovir dipivoxil followed by fasted dosing; Dosing in the fed state followed by fasted dosing
Receives: Drug: Besifovir dipivoxil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration [Cmax] of Besifovir

    The Cmax is the maximum observed plasma concentration.

    Measured: Up to 24 Hours after study drug administration

  2. Area Under the Curve [AUC] of of Besifovir

    Area under the plasma concentration versus time curve for Besifovir

    Measured: Up to 24 Hours after study drug administration

Secondary outcomes (3)

  1. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) of Besifovir

    Area under the plasma concentration-time curve from time zero to infinite time

    Measured: Up to 24 Hours after study drug administration

  2. Time to reach the Cmax [Tmax] of Besifovir

    Time to reach the Cmax of Besifovir

    Measured: Up to 24 Hours after study drug administration

  3. Apparent terminal half-life [t1/2]

    apparent terminal half-life of Besifovir

    Measured: Up to 24 Hours after study drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2019
  2. Study start13 Jan 2019
  3. Primary completion28 Jan 2019
  4. Study completion12 Feb 2019

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03885778
Sponsor's protocol ID
ID-BVCL-402
Status last verified
Mar 2019
First submitted
19 Mar 2019
Last updated
22 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Besifovir dipivoxil in people with Food Effect and Health Subjects, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.

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 4 inclusion and 35 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: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum Observed Plasma Concentration [Cmax] of Besifovir (time frame: Up to 24 Hours after study drug administration). 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?

On the ClinicalTrials.gov record for NCT03885778.

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 22 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in