Bioequivalence Study of Lu AF35700
Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)
2 other identifiers
interventional
87
1 country
1
Brief Summary
The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jan 2018
Typical duration for phase_1 healthy
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
First Submitted
Initial submission to the registry
January 3, 2018
CompletedStudy Start
First participant enrolled
January 3, 2018
CompletedFirst Posted
Study publicly available on registry
January 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2018
CompletedNovember 29, 2018
November 1, 2018
9 months
January 3, 2018
November 28, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
AUC0-72h of Lu AF35700
Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)
zero to 72 hours
Cmax of Lu AF35700
Maximum observed plasma concentration (Cmax) of Lu AF35700
zero to 72 hours
Secondary Outcomes (2)
Tmax of Lu AF35700
zero to 72 hours
AUC0-t of Lu AF35700
zero to time of the last quantifiable plasma concentration
Study Arms (6)
Lu AF35700 5 mg clinical formulation
EXPERIMENTALLu AF35700 5 mg commercial formulation
EXPERIMENTALLu AF35700 10 mg clinical formulation
EXPERIMENTALLu AF35700 10 mg commercial formulation
EXPERIMENTALLu AF35700 20 mg clinical formulation
EXPERIMENTALLu AF35700 20 mg commercial formulation
EXPERIMENTALInterventions
Lu AF35700 tablets 5 mg oral single dose
Lu AF35700 tablets 5 mg oral single dose
Lu AF35700 tablets 10 mg oral single dose
Lu AF35700 tablets 10 mg oral single dose
Lu AF35700 tablets 20 mg oral single dose
Lu AF35700 tablets 20 mg oral single dose
Eligibility Criteria
You may qualify if:
- Healthy men and women aged ≥18 and ≤55 years
- Body Mass Index (BMI) of ≥18.5 and ≤32 kg/m2
- Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination
You may not qualify if:
- The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating
- The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser
- The subject has previously been dosed with Lu AF35700
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
Covance
Leeds, United Kingdom
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Email contact via H.Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 3, 2018
First Posted
January 9, 2018
Study Start
January 3, 2018
Primary Completion
October 5, 2018
Study Completion
October 5, 2018
Last Updated
November 29, 2018
Record last verified: 2018-11