Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-16

Study Completion Date

2018-01-03

Brief Summary

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

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Detailed Description

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Conditions

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Drug Reactions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lu AF35700 and 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

Group Type EXPERIMENTAL

Lu AF35700

Intervention Type DRUG

tablets for oral use, 10 mg/day

Midazolam

Intervention Type DRUG

syrup for oral use, 4mg/day

Cocktail of CYP450 substrates

Intervention Type DRUG

Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day

Interventions

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Lu AF35700

tablets for oral use, 10 mg/day

Intervention Type DRUG

Midazolam

syrup for oral use, 4mg/day

Intervention Type DRUG

Cocktail of CYP450 substrates

Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day

Intervention Type DRUG

Eligibility Criteria

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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