Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Drug Reactions

Treatments: Drug: Cocktail of CYP450 substrates; Drug: Midazolam; Drug: Lu AF35700

Study type: Interventional

Funder types: Industry

Identifiers

NCT03195946

2016-003187-39 (EudraCT Number)

17200A

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Lu AF35700 and Cocktail of CYP450 substrates

Experimental group

Description:

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

Treatment:

Drug: Midazolam

Drug: Cocktail of CYP450 substrates

Drug: Lu AF35700