Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551623
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Drug-Drug Interactions Between TNP-2198 and Midazolam Clarithromycin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single Center Open Label Phase 1 Study in Healthy Participants to Investigate the Drug-Drug Interactions Between TNP-2198 and Midazolam Clarithromycin
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single center open label drug-drug interaction Phase 1 study of TNP-2198 in approximately 32 healthy participants includes 2 cohorts 16 participants per cohort Midazolam cohort and Clarithromycin cohort Midazolam cohort will evaluate the effect of multiple oral doses of TNP-2198 capsules on the pharmacokinetics PK parameters of a single oral dose of midazolam a cytochrome P-450 CYP 3A sensitive substrate in healthy participants Clarithromycin cohort will evaluate the effect of multiple oral doses of clarithromycin tablets a strong CYP3A and P-gp inhibitor on the PK parameters of multiple oral doses of TNP-2198 in healthy participants
Detailed Description:
Midazolam cohort Midazolam oral solution will be administered orally at a dose of 2 mg once a day within 05 hours after breakfast on Day 1 and administered following TNP-2198 capsules within 05 hours after breakfast on Day 10 TNP 2198 capsules will be administered orally at a dose of 400 mg twice a day within 05 hours after breakfast and dinner from Day 3 to Day 11 PK blood sampling and safety tests were performed at specified time points
Clarithromycin cohort TNP-2198 capsules will be administered orally at a dose of 400 mg twice a day within 05 hours after breakfast and dinner from Day 1 to Day 7 and within 05 hours after breakfast on Day 8 Clarithromycin tablets will be administered at a dose of 05 g twice a day within 05 hours after breakfast and dinner from Day 16 to Day 25 TNP-2198 capsules will be administered within 05 hours after breakfast and dinner followed by clarithromycin tablets from Day 16 to Day 22 TNP-2198 capsules will be administrated within 05 hours after breakfast followed by clarithromycin tablets on Day 23 PK blood sample collection and safety tests were performed at specified time points
Clarithromycin cohort TNP-2198 capsules will be administered orally at a dose of 400 mg twice a day within 05 hours after breakfast and dinner from Day 1 to Day 7 and within 05 hours after breakfast on Day 8 Clarithromycin tablets will be administered at a dose of 05 g twice a day within 05 hours after breakfast and dinner from Day 16 to Day 25 TNP-2198 capsules will be administered within 05 hours after breakfast and dinner followed by clarithromycin tablets from Day 16 to Day 22 TNP-2198 capsules will be administrated within 05 hours after breakfast followed by clarithromycin tablets on Day 23 PK blood sample collection and safety tests were performed at specified time points
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None