NCT04814498

Drug-Drug Interaction (DDI) Study in Healthy Volunteers

A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of BLD-0409 on the Single Dose Pharmacokinetics of a Cocktail of Probe Substrates for CYP450 Enzymes in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Blade Therapeutics · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of BLD-0409 on the Single Dose Pharmacokinetics of a Cocktail of Probe Substrates for CYP450 Enzymes in Healthy Volunteers

Detailed description

This is a single center, open label study designed to determine the effect of BLD-0409 on the PK of probe substrates and to evaluate the safety and tolerability of BLD-0409 administered alone and co-administered with a cocktail of probe substrates (i.e., Geneva cocktail less fexofenadine) in healthy adult volunteers. Geneva Cocktail (Less Fexofenadine): * CYP1A2 Caffeine 50 mg * CYP2C Flurbiprofen 10 mg * CYP2C19 Omeprazole 10 mg * CYP2D6 Dextromethorphan 10 mg * CYP3A4 Midazolam 1 mg * CYP2B6 Bupropion 20 mg

Conditions

• Drug Drug Interaction

Interventions

Type	Name	Description
DRUG	Geneva Cocktail	Fixed sequence use of drug cocktail
DRUG	BLD-0409	Fixed sequence use of active product

Timeline

• Start date: 2021-05-03
• Primary completion: 2021-09-17
• Completion: 2022-01-11
• First posted: 2021-03-24
• Last updated: 2022-05-17

Locations

1 site across 1 country: Australia