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

NCT04277897 | Unknown Phase 1

• 1 other identifier: XAXT-2019-001
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (3)

• Safety measured by adverse events

  Up to 6 Days in SAD Cohorts

• Safety measured by adverse events

  Up to 12 Days in MAD Group

• Safety measured by adverse events

  Up to 13 Days in Food-influence Group

Study Arms (5)

Drug SAD Cohorts

EXPERIMENTAL

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

Drug: Hepenofovir Fumarate Tablets Single Dose

Placebo SAD Cohorts

PLACEBO COMPARATOR

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

Drug: Placebo

Drug MAD Group

EXPERIMENTAL

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

Drug: Hepenofovir Fumarate Tablets Single Dose

Placebo MAD Group

PLACEBO COMPARATOR

Matching placebo, orally, once daily for 7 days.

Drug: Placebo

Food-influnced Group

EXPERIMENTAL

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

Drug: Hepenofovir Fumarate Tablets Dose4

Interventions

Hepenofovir Fumarate Tablets Single Dose 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).

Drug MAD Group; Drug SAD Cohorts

Placebo DRUG

Placebo to match Hepenofovir Fumarate Tablets

Placebo MAD Group; Placebo SAD Cohorts

Hepenofovir Fumarate Tablets Dose4 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.

Food-influnced Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xi'an Xintong Pharmaceutical Research Co.,Ltd.: lead

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: March 15, 2020
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02