Bioequivalence Study of Lu AF35700

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lu AF35700 20 mg clinical formulation; Drug: Lu AF35700 5 mg clinical formulation; Drug: Lu AF35700 5 mg commercial formulation; Drug: Lu AF35700 10 mg clinical formulation; Drug: Lu AF35700 10 mg commercial formulation; Drug: Lu AF35700 20 mg commercial formulation

• Registration Number: NCT03394482
• Lead Sponsor: H. Lundbeck A/S

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-09
• Primary Completion: 2018-10-05
• Study Completion: 2018-10-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lu AF35700 20 mg clinical formulation	Lu AF35700 20 mg clinical formulation	-
Lu AF35700 5 mg clinical formulation	Lu AF35700 5 mg clinical formulation	-
Lu AF35700 5 mg commercial formulation	Lu AF35700 5 mg commercial formulation	-
Lu AF35700 10 mg clinical formulation	Lu AF35700 10 mg clinical formulation	-
Lu AF35700 10 mg commercial formulation	Lu AF35700 10 mg commercial formulation	-
Lu AF35700 20 mg commercial formulation	Lu AF35700 20 mg commercial formulation	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Tmax of Lu AF35700	zero to 72 hours	Time to occurance of Cmax of Lu AF35700

Trial Locations

Locations (1)

Covance; 🇬🇧 Leeds, United Kingdom