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

Xi'an Xintong Pharmaceutical Research

Status and phase: Unknown; Phase 1

Conditions: Chronic Hepatitis b

Treatments: Drug: Hepenofovir Fumarate Tablets Single Dose; Drug: Hepenofovir Fumarate Tablets Dose4; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04277897

XAXT-2019-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 69 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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69 participants in 5 patient groups, including a placebo group

Drug SAD Cohorts

Experimental group

Description:

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

Treatment:

Drug: Hepenofovir Fumarate Tablets Single Dose

Placebo SAD Cohorts

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug MAD Group

Experimental group

Description:

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

Treatment:

Drug: Hepenofovir Fumarate Tablets Single Dose

Placebo MAD Group

Placebo Comparator group

Description:

Matching placebo, orally, once daily for 7 days.

Treatment:

Drug: Placebo

Food-influnced Group

Experimental group

Description:

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

Treatment:

Drug: Hepenofovir Fumarate Tablets Dose4