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

NCT ID: NCT04277897

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-15
• Study Completion Date: 2020-09-30

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.

Conditions

Chronic Hepatitis b

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drug SAD Cohorts

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

Group Type: EXPERIMENTAL

Hepenofovir Fumarate Tablets Single Dose

Intervention Type: DRUG

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).

Placebo SAD Cohorts

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match Hepenofovir Fumarate Tablets

Drug MAD Group

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

Group Type: EXPERIMENTAL

Hepenofovir Fumarate Tablets Single Dose

Intervention Type: DRUG

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).

Placebo MAD Group

Matching placebo, orally, once daily for 7 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match Hepenofovir Fumarate Tablets

Food-influnced Group

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

Group Type: EXPERIMENTAL

Hepenofovir Fumarate Tablets Dose4

Intervention Type: DRUG

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.

Interventions

Hepenofovir Fumarate Tablets Single Dose

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

Placebo

Placebo to match Hepenofovir Fumarate Tablets

Intervention Type: DRUG

Hepenofovir Fumarate Tablets Dose4

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xi'an Xintong Pharmaceutical Research Co.,Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

XAXT-2019-001

Identifier Type: -

Identifier Source: org_study_id