NCT04643249

Drug-drug Interaction Study of KL1333 in Healthy Subjects

A Phase I, Open-label, Fixed-sequence, Crossover, Drug-drug Interaction Study to Investigate the Inhibition Potential of KL1333 on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Abliva AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

A Phase I, Open-label, Fixed-sequence, Crossover, Drug-drug Interaction Study to Investigate the Inhibition Potential of KL1333 on CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in Healthy Subjects

Detailed description

This will be a Phase I, open-label, fixed-sequence, crossover study to investigate the effect of coadministration of KL1333 on the PK of repaglinide, caffeine, omeprazole, midazolam, bupropion, dextromethorphan, and flurbiprofen in healthy male and female subjects. Potential subjects will be screened to assess their eligibility to enter the study within 28 days prior to the first dose administration. Subjects will be admitted into the clinical research unit (CRU) on Day -1 and be confined to the CRU until discharge on Day 19. Subjects will return to the CRU for a follow-up visit 5 to 7 days after the last dose.

Conditions

• Mitochondrial Disease

Interventions

Type	Name	Description
DRUG	KL1333	Tablet
DRUG	Flurbiprofen	Tablet
DRUG	Dextromethorphan	Syrap
DRUG	Bupropion	Tablet
DRUG	Midazolam injection	solution for injection
DRUG	Omeprazole	Capsule
DRUG	Caffeine	Tablet or capsule
DRUG	Repaglinide	Tablet

Timeline

• Start date: 2020-11-10
• Primary completion: 2020-12-17
• Completion: 2020-12-17
• First posted: 2020-11-25
• Last updated: 2021-10-20

Locations

1 site across 1 country: United Kingdom