Bioequivalence Study of Lu AF35700

NCT03394482 — Phase 1, Completed, 87 participants, H. Lundbeck A/S

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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)

Registry	NCT03394482
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	87 (Actual)
Sponsor	H. Lundbeck A/S (Industry)
Conditions	Healthy
Interventions	Lu AF35700 5 mg clinical formulation, Lu AF35700 5 mg commercial formulation, Lu AF35700 10 mg clinical formulation, Lu AF35700 10 mg commercial formulation, Lu AF35700 20 mg clinical formulation, Lu AF35700 20 mg commercial formulation (Drug)
Dates	start 2018-01-03, primary completion 2018-10-05, completion 2018-10-05, first posted 2018-01-09, last updated 2018-11-29
Locations	1 site in United Kingdom

-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

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+Arms and interventions

Arm	Type	Interventions
Lu AF35700 5 mg clinical formulation	Experimental	Drug: Lu AF35700 5 mg clinical formulation
Lu AF35700 5 mg commercial formulation	Experimental	Drug: Lu AF35700 5 mg commercial formulation
Lu AF35700 10 mg clinical formulation	Experimental	Drug: Lu AF35700 10 mg clinical formulation
Lu AF35700 10 mg commercial formulation	Experimental	Drug: Lu AF35700 10 mg commercial formulation
Lu AF35700 20 mg clinical formulation	Experimental	Drug: Lu AF35700 20 mg clinical formulation
Lu AF35700 20 mg commercial formulation	Experimental	Drug: Lu AF35700 20 mg commercial formulation

Lu AF35700 5 mg clinical formulation (Drug): Lu AF35700 tablets 5 mg oral single dose
Lu AF35700 5 mg commercial formulation (Drug): Lu AF35700 tablets 5 mg oral single dose
Lu AF35700 10 mg clinical formulation (Drug): Lu AF35700 tablets 10 mg oral single dose
Lu AF35700 10 mg commercial formulation (Drug): Lu AF35700 tablets 10 mg oral single dose
Lu AF35700 20 mg clinical formulation (Drug): Lu AF35700 tablets 20 mg oral single dose
Lu AF35700 20 mg commercial formulation (Drug): Lu AF35700 tablets 20 mg oral single dose

+Outcome measures

Primary outcomes

AUC0-72h of Lu AF35700 [zero to 72 hours]: Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)
Cmax of Lu AF35700 [zero to 72 hours]: Maximum observed plasma concentration (Cmax) of Lu AF35700

Secondary outcomes

Tmax of Lu AF35700 [zero to 72 hours]: Time to occurance of Cmax of Lu AF35700
AUC0-t of Lu AF35700 [zero to time of the last quantifiable plasma concentration]: Area under the Lu AF35700 concentration-time curve from zero to time of the last quantifiable plasma concentration

+Eligibility

Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Other protocol defined inclusion and exclusion criteria may apply

+Locations (1)

Facility	City	Country	Status
Covance	Leeds	United Kingdom

+Investigators

Email contact via H.Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com

+Funding

NIH grants: 2017