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A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Entecavir Extended Release (XR) in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03239353
Recruitment Status : Completed
First Posted : August 4, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Aucta Pharmaceuticals, Inc

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.


Condition or disease Intervention/treatment Phase
HBV Drug: Entecavir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Partially-Blind, Parallel-Group, Active and Placebo Controlled Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of Entecavir Extended Release (XR) in Healthy Subjects
Actual Study Start Date : October 20, 2017
Actual Primary Completion Date : May 29, 2018
Actual Study Completion Date : June 20, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Arm Intervention/treatment
Active Comparator: 1.5 mg ETV XR tablet Drug: Entecavir
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.
Other Name: placebo

Active Comparator: 3 mg ETV XR tablet Drug: Entecavir
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.
Other Name: placebo

Active Comparator: 6 mg ETV XR tablet Drug: Entecavir
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.
Other Name: placebo

Placebo Comparator: Placebo-to-match 1.5 mg ETV XR tablet Drug: Entecavir
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.
Other Name: placebo

0.5 mg ETV IR tablet Drug: Entecavir
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.
Other Name: placebo




Primary Outcome Measures :
  1. To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses in healthy subjects. [ Time Frame: 22 days ]
    Peak Plasma Concentration(Cmax)

  2. To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses [ Time Frame: 22 days ]
    Area under the plasma concentration versus time curve (AUC)

  3. To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses [ Time Frame: 22 days ]
    peak time (Tmax)

  4. To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses [ Time Frame: 22 days ]
    Relative bioavailability (Frelative)

  5. To characterize the Pharmacokinetics (PK) of ETV XR tablet after single oral doses [ Time Frame: 22 days ]
    half life (t1/2)


Secondary Outcome Measures :
  1. To assess ETV XR tablet in healthy subjects. [ Time Frame: 22 days ]
    adverse events

  2. To assess ETV XR tablet in healthy subjects. [ Time Frame: 22 day ]
    laboratory abnormalities

  3. To assess ETV XR tablet in healthy subjects. [ Time Frame: 22 days ]
    vital signs

  4. To assess ETV XR tablet in healthy subjects. [ Time Frame: 22 days ]
    12-lead electrocardiograms (ECGs)

  5. To evaluate the dose linearity of ETV XR tablet [ Time Frame: 60 days ]
    1.5mg, 3mg and 6mg PK linearity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Exclusion criteria:

A subject meeting any of the following criteria will be excluded from the study:

  1. 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;
  2. Has a positive result from serology examination for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
  3. There are drug-dependent or drug abuse history, or urine drug abuse screening positive;
  4. 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;
  5. 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;
  6. Participated in any drug or medical device clinical trial within 3 months prior to screening;
  7. Pregnant or breastfeeding women or pregnancy testing is positive;
  8. Have taken any prescription medications, over-the-counter medications, supplements or herbal products within 14 days, or 5 half-lives (whichever is longer), of study drug dosing, with the exception of paracetamol and hormonal contraceptive medications, unless in the opinion of the Investigator and/or Medical Monitor that the substance would not have any material impact on participant safety or the quality of study data;
  9. Donated blood greater than 400 mL or significant blood loss equivalent to 400 mL or received blood transfusion within 3 months of screening; Or donated blood greater than 200 ml or significant blood loss equivalent to 200 mL within 1 months prior to screening;
  10. Has infectious diseases within four weeks at screening (in the opinion of the investigator would pose a risk for participation in this study), severe trauma, or a history of major surgery within 3 months;
  11. Cannot tolerate venepuncture or cannulation;
  12. Consumption of grapefruit, grapefruit juice, cranberries, or products containing Seville oranges (fruit juices, marmalade, jam, etc) within 7 days prior to study drug dosing; consumption of caffeine-containing products within 48 hours of study drug dosing;
  13. Have been vaccinated within 90 days of study dosing, with the exception of licensed intranasal or intramuscular influenza vaccine ≤ 14 days prior to dosing.
  14. Have severe multiple allergies and / or severe allergies (including latex / heparin allergy) history, or has hypersensitivity or significant intolerance to prescription drugs or over-the-counter drugs or food;
  15. Subjects who, in the opinion of the Investigator, should not participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03239353


Locations
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Australia, Western Australia
Linear Clinical Research Ltd
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Aucta Pharmaceuticals, Inc
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Responsible Party: Aucta Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT03239353    
Other Study ID Numbers: UAP008C001
First Posted: August 4, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Entecavir
Antiviral Agents
Anti-Infective Agents