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Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195946
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Drug Reactions Drug: Lu AF35700 Drug: Midazolam Drug: Cocktail of CYP450 substrates Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 16, 2017
Actual Primary Completion Date : January 3, 2018
Actual Study Completion Date : January 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Lu AF35700
tablets for oral use, 10 mg/day

Drug: Midazolam
syrup for oral use, 4mg/day

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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195946


Locations
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United Kingdom
Covance Clinical Research Unit Ltd
Leeds, United Kingdom
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com

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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT03195946    
Other Study ID Numbers: 17200A
2016-003187-39 ( EudraCT Number )
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Midazolam
Dextromethorphan
Omeprazole
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents