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OpenTrials
Completed

NCT Number: NCT03195946

Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes

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

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Key information

Conditions

Drug Reactions Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Ltd

Leeds, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lu AF35700

Drug

tablets for oral use, 10 mg/day

midazolam

Drug

syrup for oral use, 4mg/day

Cocktail of CYP450 substrates

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

Primary outcomes

  1. AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity

    Time frame: 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

  2. Cmax: Maximum observed concentration

    Time frame: 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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, Multiple-dose Study to Investigate the Effects of Multiple Doses of Lu AF35700 on the Pharmacokinetics of Cytochrome P450 (CYP450) Substrates Dextromethorphan (CYP2D6), Caffeine (CYP1A2), Omeprazole (CYP2C19), and Midazolam (CYP3A4/5) in Healthy Young Adults

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 22, 2017
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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