NCT05368831

Open-label Study to Evaluate the Effects of NST-1024 on the PK of Multiple Drugs in Healthy Subjects

A Phase 1, Open-label Study to Evaluate the Effects of NST-1024 on the Pharmacokinetics of Caffeine, Flurbiprofen, Omeprazole, Metoprolol, and Midazolam in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: NorthSea Therapeutics B.V. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Phase 1, open label study to evaluate the effects of NST-1024 on the pharmacokinetics (PK) of caffeine (and paraxanthine), flurbiprofen, omeprazole, metoprolol, and midazolam (and 1-hydroxymidazolam) in healthy male and female subjects.

Detailed description

Up to 21 subjects will be enroled to ensure that 18 subjects complete the study. All subjects will receive each of the following treatments: * Day 1: single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam * Days 8 to 22: oral doses of 200 mg NST-1024 qd multiple-dose regimen * Day 8: single oral dose of 100 mg caffeine, 50 mg flurbiprofen, 20 mg omeprazole, 100 mg metoprolol, and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024 * Day 21: single oral dose of 100 mg caffeine and 2.5 mg midazolam coadministered with an oral dose of 200 mg NST-1024.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	NST-1024	Drug Drug interactions between NST-1024 and caffeine (and paraxanthine), flurbiprofen, omeprazole, metoprolol, and midazolam

Timeline

• Start date: 2022-07-19
• Primary completion: 2022-09-07
• Completion: 2022-09-07
• First posted: 2022-05-10
• Last updated: 2024-03-08
• Results posted: 2024-03-08

Locations

1 site across 1 country: United Kingdom