Back to resultsEffects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes
Primary Purpose
Drug Reactions
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Lu AF35700
Midazolam
Cocktail of CYP450 substrates
Sponsored by
About this trial
This is an interventional treatment trial for Drug Reactions
Eligibility 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
Sites / Locations
- Covance Clinical Research Unit Ltd
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lu AF35700 and Cocktail of CYP450 substrates
Arm 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
Outcomes
Primary Outcome Measures
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
Cmax: Maximum observed concentration
Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03195946
Brief Title
Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
January 3, 2018 (Actual)
Study Completion Date
January 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will help determine which types of drugs that may interact with Lu AF35700
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Reactions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lu AF35700 and Cocktail of CYP450 substrates
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Lu AF35700
Intervention Description
tablets for oral use, 10 mg/day
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
syrup for oral use, 4mg/day
Intervention Type
Drug
Intervention Name(s)
Cocktail of CYP450 substrates
Intervention Description
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 Measure Information:
Title
AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity
Description
Area under the plasma concentration-time curve from zero to infinity for oral midazolam and metabolite and all drug cocktail components and their metabolites
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.
Title
Cmax: Maximum observed concentration
Description
Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
Covance Clinical Research Unit Ltd
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Repeated Doses of Lu AF35700 on Drug Metabolizing Enzymes
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