NCT03239353

Brief Summary

This is a phase 1, randomized, parallel-group, single-center study in healthy adult subjects. The study will be conducted in two parts sequentially: Part 1 is an open-label, two-arm, active-controlled design to evaluate the PK and safety of single oral dose of ETV XR tablet (1.5 mg) in healthy subjects. Part 1 will consist of 16 healthy subjects. Part 2 is a double-blind, three-arm, placebo-controlled design to evaluate the PK and safety of higher oral doses of ETV XR tablet (3 mg and 6 mg) in healthy subjects. Part 2 will consist of 24 healthy subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 20, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2018

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2018

Completed
Last Updated

June 27, 2018

Status Verified

June 1, 2018

Enrollment Period

7 months

First QC Date

July 27, 2017

Last Update Submit

June 25, 2018

Conditions

HBV

Outcome Measures

Primary Outcomes (5)

  • To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses in healthy subjects.

    Peak Plasma Concentration(Cmax)

    22 days

  • To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses

    Area under the plasma concentration versus time curve (AUC)

    22 days

  • To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses

    peak time (Tmax)

    22 days

  • To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses

    Relative bioavailability (Frelative)

    22 days

  • To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses

    half life (t1/2)

    22 days

Secondary Outcomes (5)

  • To assess ETV XR tablet in healthy subjects.

    22 days

  • To assess ETV XR tablet in healthy subjects.

    22 day

  • To assess ETV XR tablet in healthy subjects.

    22 days

  • To assess ETV XR tablet in healthy subjects.

    22 days

  • To evaluate the dose linearity of ETV XR tablet

    60 days

Study Arms (5)

1.5 mg ETV XR tablet

ACTIVE COMPARATOR
Drug: Entecavir

3 mg ETV XR tablet

ACTIVE COMPARATOR
Drug: Entecavir

6 mg ETV XR tablet

ACTIVE COMPARATOR
Drug: Entecavir

Placebo-to-match 1.5 mg ETV XR tablet

PLACEBO COMPARATOR
Drug: Entecavir

0.5 mg ETV IR tablet

OTHER
Drug: Entecavir

Interventions

EntecavirDRUG

Study drug (entecavir or placebo) will be administered with 240 mL of water following an overnight fast (no food or drink, except water, for at least 10 hours). Subjects will be required to fast (no food or beverages other than water) until after collection of the 4-hour blood draw.

Also known as: placebo
0.5 mg ETV IR tablet1.5 mg ETV XR tablet3 mg ETV XR tablet6 mg ETV XR tabletPlacebo-to-match 1.5 mg ETV XR tablet

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Male or female aged between 18 and 55 years (inclusive). Body weight ≥ 50 kg for males, and ≥45 kg for females and Body Mass Index (BMI) between 18 and 28 kg/m2 (inclusive), BMI(kg/m2) = body weight(kg)/{height(m)}2;
  • Ability to fully understand the purpose, characteristic, method and the possible adverse effects of the trial, and voluntarily signed Informed Consent obtained before any trial-related procedures are performed;
  • Ability to comply with the requirements of this trial protocol, including refrain from strenuous exercise/activity 3 days prior to Day -1 (admission) and for 3 days prior to the Day 8, Day 15 and the final follow-up visit on Day 22through the duration of the study
  • Have a creatinine clearance (CLCr) ≥ 80 mL/min;
  • Male subjects and female subjects of child bearing potential must be willing to practice effective contraception during the study and been willing and able to continue contraception for 90 days after their dose of the study treatment;
  • Male subjects must refrain from sperm donation from Day -1 through completion of the study and continuing for at least 90 days from the date of last dose of study drug;
  • Subjects must refrain from blood donation from Screening through completion of the study and continuing for at least 30 days from date of last dose of study drug;
  • AST, ALT and bilirubin ≤ 1.5xULN (isolated bilirubin \> 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%);
  • Must, in the opinion of the Investigator, be in good health based upon medical history, physical examination (including vital signs), and screening laboratory evaluations (hematology, chemistry, and urinalysis must fall within the normal range of the central laboratory reference ranges unless the results have been determined by the Investigator to have no clinical significance).
  • A subject meeting any of the following criteria will be excluded from the study:
  • Current or a history of any clinically significant medical illness or medical disorders the investigator considers should exclude including (but not limited to) neurological disease, cardiovascular disease, hepatic or renal disease, gastrointestinal tract disease (such as dysphagia, gastrointestinal ulcers), respiratory disease, metabolism, skeletal system diseases or other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs;
  • Has a positive result from serology examination for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
  • There are drug-dependent or drug abuse history, or urine drug abuse screening positive;
  • Subject smoked more than 5 cigarettes or other tobacco or nicotine-containing products within 1 month prior to dosing and is unwilling to abstain from smoking for 48 hours prior to check-in (Day -1)ing, for the duration of the confinement period and at each follow-up visit;
  • Has used an alcohol consumption of more than 14 units of alcohol per week (1 unit of alcohol is equivalent to 360 mL of beer or 45 mL of spirits with 40 % of alcohol or 150 mL of wine) within 6 months prior to screening or taking products containing alcohol 48 hours prior to IMP administration;
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linear Clinical Research Ltd

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Interventions

entecavir

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 4, 2017

Study Start

October 20, 2017

Primary Completion

May 29, 2018

Study Completion

June 20, 2018

Last Updated

June 27, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)