The Safety and Tolerability of Metacavir Enteric-coated Capsules in Healthy Adult Volunteers
A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design Conducted in Chinese Healthy Adult Volunteers
1 other identifier
interventional
48
1 country
1
Brief Summary
A Safety and Tolerability Evaluation of Ascending Single Oral Doses of Metacavir Enteric-coated Capsules Using a Randomized，Double-blind, Placebo-controlled Design conducted in Chinese Healthy Adult Volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 12, 2017
CompletedFirst Posted
Study publicly available on registry
June 2, 2017
CompletedJune 2, 2017
May 1, 2017
4 months
May 12, 2017
May 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events refer to any adverse and unexpected vital signs and laboratory tests，symptoms or temporary illness.
Baseline, up to Day 7
Study Arms (7)
PNA 40mg
EXPERIMENTALMetacavir Enteric-coated Capsules,oral before meal The beginning dose is 40mg,If no adverse effects were observed in 40 mg, the next dose group was started of 80mg.
PNA 80mg
EXPERIMENTALMetacavir Enteric-coated Capsules,oral before meal The single dose is 80mg,If no adverse effects were observed in 80 mg, the next dose group was started of 160mg.
PNA 160mg
EXPERIMENTALMetacavir Enteric-coated Capsules,oral before meal The single dose is 160mg,If no adverse effects were observed in 160 mg, the next dose group was started of 240mg.
PNA 240mg
EXPERIMENTALMetacavir Enteric-coated Capsules,oral before meal The single dose is 240mg,If no adverse effects were observed in 240 mg, the next dose group was started of 360mg.
PNA 360mg
EXPERIMENTALMetacavir Enteric-coated Capsules,oral before meal The single dose is 360mg,If no adverse effects were observed in 360 mg, the next dose group was started of 480mg.
PNA 480mg
EXPERIMENTALMetacavir Enteric-coated Capsules,oral before meal The single dose is 480mg.
PNA Placebo
PLACEBO COMPARATORMetacavir Enteric-coated Capsules Placebo,oral before meal The beginning dose is 40mg/d, the dose escalation method is 40mg/80mg/160mg/240mg/360mg/480mg
Interventions
The beginning dose is 40mg.
The single dose is 160mg.
The single dose is 240mg.
The single dose is 360mg.
The single dose is 480mg.
The beginning dose is 40mg/d, the dose escalation method is 40mg/80mg/160mg/240mg/360mg/480mg.
Eligibility Criteria
You may qualify if:
- Healthy volunteers aged 18 to 45 years old ;
- Body mass index (BMI) above/equal 18 and below 28 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;
- No smoking in a year before post-dosing of study drug;
- Give their signed written informed consent to participate.
You may not qualify if:
- Subjects who have clinically significant abnormal laboratory test results;
- Subjects with clinically significant abnormal ECG;
- Subjects with cardiac or blood disease affecting the safety and pharmacokinetics;
- Subjects with liver or renal disease affecting the safety and pharmacokinetics;
- Subjects with digestive system disease affecting the safety of study drug;
- Subjects with other acute or chronic disease affecting pharmacokinetics and product metabolism;
- 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;
- Subjects, who in the opinion of the investigator, significantly abuse alcohol;
- 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;
- Smokers(use tobacco products in a year before post-dosing of study drug);
- 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 administration of Investigational Product;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yimin Mao
RenJi Hospital
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 12, 2017
First Posted
June 2, 2017
Study Start
December 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
June 2, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share