HBV
Conditions
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.
Interventions
DRUGEntecavir
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.
Sponsors
Aucta Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects will be considered for enrollment in the study if they meet all of the inclusion criteria and none of the
Exclusion criteria
. 1. 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; 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; 3. 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 4. Have a creatinine clearance (CLCr) ≥ 80 mL/min; 5. 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; 6. 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; 7. 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; 8. AST, ALT and bilirubin ≤ 1.5xULN (isolated bilirubin \> 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%); 9. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses in healthy subjects. | 22 days | Peak Plasma Concentration(Cmax) |
| To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses | 22 days | Area under the plasma concentration versus time curve (AUC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess ETV XR tablet in healthy subjects. | 22 days | adverse events |
| To evaluate the dose linearity of ETV XR tablet | 60 days | 1.5mg, 3mg and 6mg PK linearity |
Countries
Australia
Outcome results
None listed