A Food Effect Study of Besifovir in Healthy Subjects

NCT03885778 | Completed Phase 4

• 1 other identifier: ID-BVCL-402
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Food Effect; Health Subjects

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration [Cmax] of Besifovir

  The Cmax is the maximum observed plasma concentration.

  Up to 24 Hours after study drug administration

• Area Under the Curve [AUC] of of Besifovir

  Area under the plasma concentration versus time curve for Besifovir

  Up to 24 Hours after study drug administration

Secondary Outcomes (3)

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

  Up to 24 Hours after study drug administration

• Time to reach the Cmax [Tmax] of Besifovir

  Up to 24 Hours after study drug administration

• Apparent terminal half-life [t1/2]

  Up to 24 Hours after study drug administration

Other Outcomes (1)

• Safety of Besifovir: incidence of treatment emergent adverse event [TEAE]'s, abnormalities

  Up to 14 days after last study drug administration

Study Arms (2)

A-fasted dosing followed by fed dosing

EXPERIMENTAL

Fasted dosing of Besifovir dipivoxil followed by fed dosing; Dosing in the fasted state followed by fed dosing

Drug: Besifovir dipivoxil

B-fed dosing followed by fasted dosing

EXPERIMENTAL

Fed dosing of Besifovir dipivoxil followed by fasted dosing; Dosing in the fed state followed by fasted dosing

Drug: Besifovir dipivoxil

Interventions

Besifovir dipivoxil DRUG

150mg Besifovir dipivoxil, single dose, oral

Also known as: Besivo tab

A-fasted dosing followed by fed dosing; B-fed dosing followed by fasted dosing

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Inje University Busan Paik Hospital

Busan, South Korea

Location

Study Officials

• jong-Lyul GhimK

  Inje University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 22, 2019
• Study Start: January 13, 2019
• Primary Completion: January 28, 2019
• Study Completion: February 12, 2019
• Last Updated: March 22, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)