Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes
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
2 other identifiers
interventional
24
1 country
1
Brief Summary
This study will help determine which types of drugs that may interact with Lu AF35700
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2017
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 16, 2017
CompletedFirst Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2018
CompletedJanuary 8, 2018
January 1, 2018
7 months
June 20, 2017
January 5, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity
Area under the plasma concentration-time curve from zero to infinity for oral midazolam and metabolite and all drug cocktail components and their metabolites
Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for cocktail components.
Cmax: Maximum observed concentration
Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites
Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for Cocktail components.
Study Arms (1)
Lu AF35700 and Cocktail of CYP450 substrates
EXPERIMENTALDay 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
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or lactating women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
Covance Clinical Research Unit Ltd
Leeds, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 22, 2017
Study Start
June 16, 2017
Primary Completion
January 3, 2018
Study Completion
January 3, 2018
Last Updated
January 8, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share