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

Chronic Hepatitis b Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04277897
• Other study ID #: XAXT-2019-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 15, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: February 2020
• Source: Xi'an Xintong Pharmaceutical Research Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 69
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• 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).
• Placebo
Placebo to match Hepenofovir Fumarate Tablets
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xi'an Xintong Pharmaceutical Research Co.,Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by adverse events		Up to 6 Days in SAD Cohorts
Primary	Safety measured by adverse events		Up to 12 Days in MAD Group
Primary	Safety measured by adverse events		Up to 13 Days in Food-influence Group