The Tolerability and Pharmacokinetics Clinical Trial of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers

NCT03180333 | Completed Phase 1

• 1 other identifier: PNA-20120309-V1
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Conduct in Chinese healthy adult subjects:1.To observe the safety and tolerability of multiple-dose oral administration of different doses of PNA;2.By measuring the changing drug concentration in the plasma and urine after a single oral administration of different doses of PNA on the condition of fasting, the pharmacokinetic parameters of the single dose are estimated;3.By measuring the changing drug concentration in the plasma of PNA after a multiple-dose oral administration on the condition of fasting, the pharmacokinetic parameters of multiple-dose are estimated, and a basis for dosage regimens of the clinical research phase Ⅱ is provided;4.To study the effects of diet on the pharmacokinetic parameters via the changes of concentration of PNA in plasma after high-fat and high-calorie food.

Conditions

Chronic Hepatitis B

Keywords

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• TEAEs

  Frequency of treatment-emergent adverse events

  day 1 to day 14

Secondary Outcomes (3)

• AUC

  day 1 to day 7

• Cmax

  day 1 to day 7

• T1/2

  day 1 to day 7

Study Arms (5)

PNA 1

EXPERIMENTAL

Multiple dosing tolerance test:Metacavir Enteric-coated Capsules 160mg/320mg,once a day,continuous administration for 7 days;

Drug: PNA

PNA placebo

PLACEBO COMPARATOR

Multiple dosing tolerance test:Metacavir Enteric-coated Capsules placebo 160mg/320mg,once a day,continuous administration for 7 days

Drug: PNA placebo

PNA 2

EXPERIMENTAL

Single dosing pharmacokinetic test:Metacavir Enteric-coated Capsules 80mg/160mg/320mg,single-dose;

Drug: PNA

PNA 3

EXPERIMENTAL

Multiple dosing pharmacokinetic test:Metacavir Enteric-coated Capsules 160mg/320mg,once a day,continuous administration for 6 days;

Drug: PNA

PNA 4

EXPERIMENTAL

The effect of diet:Metacavir Enteric-coated Capsules 160mg,before and after meal.

Drug: PNA

Interventions

PNA DRUG

Also known as: Metacavir Enteric-coated Capsules

PNA 1; PNA 2; PNA 3; PNA 4

PNA placebo DRUG

Also known as: Metacavir Enteric-coated Capsules placebo

PNA placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers aged 18 to 45 years old ;
• Body mass index (BMI) above/equal 19 and below 24 kg/m2;
• Child bearing potential, has a negative serum pregnancy test at screening period, and agrees to use contraceptions consistently and correctly in 14 days after dosing;
• Subjects with no cardiovascular, liver, kidney, digestive tract, nervous and mental and other acute or chronic diseases that may affect the safety and pharmacokinetic of drug;
• Signed informed consent voluntarily.

You may not qualify if:

• Abnormal clinically significant laboratory results;
• Abnormal clinically significant electrocardiogram (ECG);
• A positive hepatitis B surface antigen, hepatitis C or HIV test result;
• History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes;
• Addicted to smoking and drinking;
• Drink in 36 hours before post-dosing of study drug;
• Ingest any foods or beverages which may affect pharmacokinetics;
• Drug abuse,a history of poisoning;
• Subjects who had received other medications within 2 weeks prior to the first administration of Investigational Product，and the original and main metabolites were not completely eliminated ;
• Subjects who participated in any other clinical trials within 3 months prior to the first administration of Investigational Product;
• Subjects who had suffered from hemorrhage or blood donation over 200ml will be excluded;
• Subjects over exercised accompanied with fatigue and muscle aches within 1 week period to the first administration of Investigational Product;
• Children,women who are pregnant,lactating,with childbearing potential and who are using acyeterions;
• Subjects in the opinion of the investigator, could not participate in this study.

Sponsors & Collaborators

• Guangzhou Yipinhong Pharmaceutical CO.,LTD: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

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 Officials

• Hongwei Fan

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Ruifang Wang

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 8, 2017
• Study Start: March 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)