Ignite Creation Date:
2024-05-06 @ 7:40 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06093308
Status:
COMPLETED
Last Update Posted:
2023-10-23
First Post:
2023-09-25
Brief Title:
A Study in Elderly Chinese Subjects With Underlying Diseases
Sponsor:
Shanghai Vinnerna Biosciences Co Ltd
Organization:
Shanghai Vinnerna Biosciences Co Ltd
Study Overview
Official Title:
A Phase 1 Open-label Single-and Multiple-dose Study to Evaluate the Safety Tolerability and Pharmacokinetics of JT001 Administered Orally in Elderly Chinese Subjects With Underlying Diseases
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate the safety and tolerability of oral JT001 tablets in elderly subjects with underlying diseases
Evaluate the pharmacokinetic characteristics of JT001 tablets orally administered to elderly subjects with underlying diseases
Explore the drug drug interactions between JT001 tablets and some drugs in elderly subjects with underlying diseases who have been orally administered multiple times
Evaluate the pharmacokinetic characteristics of JT001 tablets orally administered to elderly subjects with underlying diseases
Explore the drug drug interactions between JT001 tablets and some drugs in elderly subjects with underlying diseases who have been orally administered multiple times
Detailed Description:
The open-label single-center phase I study to evaluate the safety tolerability and pharmacokinetics of JT001 single-and multiple-dose administered orally in elderly subjects with underlying diseasesApproximately 16 to 18 elderly subjects will be enrolled aging beyound 60 years
All subjects received JT001 oral administration after meals D1 06g twice a day D2-D5 03g twice a day D6 03g administered once in the morningBlood samples will be collected at times sufficient to adequately define the pharmacokinetics of JT001 active metabolite116N-1 in elderly groupsThe steady-state trough concentration of therapeutic drug monitoring TDM for the basic medication of the subjects will be collected as well
Subjects will be admitted to the phase I clinical trial ward 2 days before administration D-2 and will not be allowed to leave until all examinations and assessments are completed on day 8 Telephone follow-up will be performed on day 12 1 day
All subjects received JT001 oral administration after meals D1 06g twice a day D2-D5 03g twice a day D6 03g administered once in the morningBlood samples will be collected at times sufficient to adequately define the pharmacokinetics of JT001 active metabolite116N-1 in elderly groupsThe steady-state trough concentration of therapeutic drug monitoring TDM for the basic medication of the subjects will be collected as well
Subjects will be admitted to the phase I clinical trial ward 2 days before administration D-2 and will not be allowed to leave until all examinations and assessments are completed on day 8 Telephone follow-up will be performed on day 12 1 day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None