Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06593457
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
A Food-Effect Drug-Drug Interaction and Pharmacokinetics Study of NX-5948 in Healthy Adult Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 2-Part Placebo-Controlled Double-Blinded Study to Assess the Effect of Food and Drug-Drug Interaction of Fluconazole on the Pharmacokinetics of NX-5948
Status:
RECRUITING
Status Verified Date:
2024-09
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 Phase 1 2-part double-blinded with respect to NX-5948placebo placebo-controlled study Part 1 is a randomized 3 period cross-over food-effect FE and drug-drug interaction DDI study Part 2 is a single-period PK evaluation study
Detailed Description:
Part 1
Periods 1 and 2 Subjects will be randomized to 1 of 2 treatment sequences in a 11 ratio In each treatment sequence subjects will be randomized to receive either active NX-5948 or placebo in a 72 ratio Subjects will receive a single dose of NX-5948 or placebo under fasting or fed conditions as per randomization schedule to evaluate the effect of food on the single- dose pharmacokinetics PK of NX-5948 in healthy subjects
Period 3 Fluconazole will be administered every day for 8 consecutive days with a single dose of NX-5948placebo coadministered on Day 4 to evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects
Part 2
Subjects will be randomized to receive either active NX-5948 or placebo to assess single-period PK
Parts 1 and 2 Safety will be monitored throughout the study by repeated clinical and laboratory evaluations
Periods 1 and 2 Subjects will be randomized to 1 of 2 treatment sequences in a 11 ratio In each treatment sequence subjects will be randomized to receive either active NX-5948 or placebo in a 72 ratio Subjects will receive a single dose of NX-5948 or placebo under fasting or fed conditions as per randomization schedule to evaluate the effect of food on the single- dose pharmacokinetics PK of NX-5948 in healthy subjects
Period 3 Fluconazole will be administered every day for 8 consecutive days with a single dose of NX-5948placebo coadministered on Day 4 to evaluate the effect of fluconazole on the single dose PK of NX-5948 in healthy subjects
Part 2
Subjects will be randomized to receive either active NX-5948 or placebo to assess single-period PK
Parts 1 and 2 Safety will be monitored throughout the study by repeated clinical and laboratory evaluations
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