Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes

Phase 1

Completed

• Conditions: Drug Reactions
• Interventions: Drug: Lu AF35700; Drug: Midazolam; Drug: Cocktail of CYP450 substrates

• Registration Number: NCT03195946
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

This study will help determine which types of drugs that may interact with Lu AF35700

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-16
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-22
• Status Verified: 2018-01
• Primary Completion: 2018-01-03
• Study Completion: 2018-01-03
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Body weight at least 50 kg and Body Mass Index 19 - 30 kg/m2
• Good general health ascertained by a detailed medical history, laboratory tests and physical examination

Exclusion Criteria

-Pregnant or lactating women

Other protocol defined inclusion and exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lu AF35700 and Cocktail of CYP450 substrates	Midazolam	Day 1 oral midazolam administration, Day 2 Cocktail of CYP450 substrates administration. Daily Lu AF35700 administration from Day 5 to Day 28 with co-administration on Day 27 with oral midazolam and Day 28 with CYP450 substrate cocktail
Lu AF35700 and Cocktail of CYP450 substrates	Cocktail of CYP450 substrates	Day 1 oral midazolam administration, Day 2 Cocktail of CYP450 substrates administration. Daily Lu AF35700 administration from Day 5 to Day 28 with co-administration on Day 27 with oral midazolam and Day 28 with CYP450 substrate cocktail
Lu AF35700 and Cocktail of CYP450 substrates	Lu AF35700	Day 1 oral midazolam administration, Day 2 Cocktail of CYP450 substrates administration. Daily Lu AF35700 administration from Day 5 to Day 28 with co-administration on Day 27 with oral midazolam and Day 28 with CYP450 substrate cocktail

Primary Outcome Measures

Name	Time	Method
AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity	Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for cocktail components.	Area under the plasma concentration-time curve from zero to infinity for oral midazolam and metabolite and all drug cocktail components and their metabolites
Cmax: Maximum observed concentration	Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for Cocktail components.	Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites

Trial Locations

Locations (1)

Covance Clinical Research Unit Ltd; 🇬🇧 Leeds, United Kingdom