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A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.

Primary Purpose

Chronic Hepatitis b

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Hepenofovir Fumarate Tablets Single Dose

Placebo

Hepenofovir Fumarate Tablets Dose4

About this trial

This is an interventional treatment trial for Chronic Hepatitis b

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Able to understand the nature of the study, comply with the protocol, and provide informed consent.
Subjects willing to adhere to protocol requirements and to finish the study.
Subjects were willing to use methods of contraception from the time of screen to 6 months post the last dose administration.
Subjects aged between 18 and 55 years (both inclusive).
Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)) ,with minimum of 50 kg weight for male, 45 kg weight for famale.
Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.

Exclusion Criteria:

History or presence of significant smoking (more than 5 cigarettes/day prior to 3 months the first dose of the study drug).
Hypersensitivity to different kinds of drugs and food.
Presence of significant alcoholism or drug abuse.
Volunteer who have donated blood or lose blood(>450mL)within past 90 days prior to the first dose of the study drug.
Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 28 days prior to dosing of the study.
Use of any prescribed medication or OTC medicinal products during the last 14 days prior to dosing of the study.
Consumption of spcial food(including gragon fruit, mango, grapefruits) or strenuous excercise,or other factors which may effect the absorption,distribution,metabolism,excretion of drugs for within 2 weeks prior to dosing of the study.
Any treatment which could bring about induction or inhibition of CYP3A4.
Volunteer who have participation in a drug research study within past 90 days prior to the first dose of the study drug.
Difficulty in swallowing or other gastrointestinal disease or disorder.
Presence of an abnormal electrocardiogram (ECG), which was clinically significant.
Female subjects who were breast-feeding or had a positive pregnancy test at screening or at any time during the study.
Subjects with abnormal health as determined by personal medical history, clinical examination and laboratory examinations,which was clinically significant.
Subjects who, in the opinion of the Investigator, should not participate in the study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Drug SAD Cohorts

Placebo SAD Cohorts

Drug MAD Group

Placebo MAD Group

Food-influnced Group

Arm Description

Hepenofovir Fumarate Tablets Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily in one single administration.

Matching placebo, orally, once daily in one single administration.

Hepenofovir Fumarate Tablets Dose 3 orally, once daily for 7 days.

Matching placebo, orally, once daily for 7 days.

Hepenofovir Fumarate Tablets Dose 4 orally, once daily in one single administration in fast condition,cross-over 7 days later in fed condition.

Outcomes

Primary Outcome Measures

Safety measured by adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT04277897

First Posted

February 18, 2020

Last Updated

February 18, 2020

Sponsor

Xi'an Xintong Pharmaceutical Research Co.,Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04277897

Brief Title

A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.

Official Title

A Phase Ia Single-center,Randomized,Double-blind,Placebo-controled Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 15, 2020 (Anticipated)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xi'an Xintong Pharmaceutical Research Co.,Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers

Detailed Description

It's a single-center,randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of Hepenofovir Fumarate Tablets in healthy adult subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis b

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

69 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drug SAD Cohorts

Arm Type

Experimental

Arm Description

Hepenofovir Fumarate Tablets Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily in one single administration.

Arm Title

Placebo SAD Cohorts

Arm Type

Placebo Comparator

Arm Description

Matching placebo, orally, once daily in one single administration.

Arm Title

Drug MAD Group

Arm Type

Experimental

Arm Description

Hepenofovir Fumarate Tablets Dose 3 orally, once daily for 7 days.

Arm Title

Placebo MAD Group

Arm Type

Placebo Comparator

Arm Description

Matching placebo, orally, once daily for 7 days.

Arm Title

Food-influnced Group

Arm Type

Experimental

Arm Description

Hepenofovir Fumarate Tablets Dose 4 orally, once daily in one single administration in fast condition,cross-over 7 days later in fed condition.

Intervention Type

Drug

Intervention Name(s)

Hepenofovir Fumarate Tablets Single Dose

Intervention Description

Oral Tablet; Subjects will receive either a single dose of Hepenofovir Fumarate Tablets on Day 1 only (SAD), once daily dosing of HTS starting on Day 1 through Day 7 (MAD).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to match Hepenofovir Fumarate Tablets

Intervention Type

Drug

Intervention Name(s)

Hepenofovir Fumarate Tablets Dose4

Intervention Description

Oral Tabet; Subjects will receive Hepenofovir Fumarate Tablets Dose4 on Day 1 in fast condition, then receive Hepenofovir Fumarate Tablets Dose4 on Day 8 in fed condition.

Primary Outcome Measure Information:

Title

Safety measured by adverse events

Time Frame

Up to 6 Days in SAD Cohorts

Title

Safety measured by adverse events

Time Frame

Up to 12 Days in MAD Group

Title

Safety measured by adverse events

Time Frame

Up to 13 Days in Food-influence Group

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Able to understand the nature of the study, comply with the protocol, and provide informed consent. Subjects willing to adhere to protocol requirements and to finish the study. Subjects were willing to use methods of contraception from the time of screen to 6 months post the last dose administration. Subjects aged between 18 and 55 years (both inclusive). Subject's weight within normal range according to normal values for Body Mass Index (19.00 to 26.00 kg/m2 (both inclusive)) ,with minimum of 50 kg weight for male, 45 kg weight for famale. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range. Exclusion Criteria: History or presence of significant smoking (more than 5 cigarettes/day prior to 3 months the first dose of the study drug). Hypersensitivity to different kinds of drugs and food. Presence of significant alcoholism or drug abuse. Volunteer who have donated blood or lose blood(>450mL)within past 90 days prior to the first dose of the study drug. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 28 days prior to dosing of the study. Use of any prescribed medication or OTC medicinal products during the last 14 days prior to dosing of the study. Consumption of spcial food(including gragon fruit, mango, grapefruits) or strenuous excercise,or other factors which may effect the absorption,distribution,metabolism,excretion of drugs for within 2 weeks prior to dosing of the study. Any treatment which could bring about induction or inhibition of CYP3A4. Volunteer who have participation in a drug research study within past 90 days prior to the first dose of the study drug. Difficulty in swallowing or other gastrointestinal disease or disorder. Presence of an abnormal electrocardiogram (ECG), which was clinically significant. Female subjects who were breast-feeding or had a positive pregnancy test at screening or at any time during the study. Subjects with abnormal health as determined by personal medical history, clinical examination and laboratory examinations,which was clinically significant. Subjects who, in the opinion of the Investigator, should not participate in the study.

12. IPD Sharing Statement

Learn more about this trial

A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers.

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