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)

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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 clinical formulation; Drug: Lu AF35700 20 mg commercial formulation

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • Covance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lu AF35700 5 mg clinical formulation	Drug: Lu AF35700 5 mg clinical formulation; Lu AF35700 tablets 5 mg oral single dose
Experimental: Lu AF35700 5 mg commercial formulation	Drug: Lu AF35700 5 mg commercial formulation; Lu AF35700 tablets 5 mg oral single dose
Experimental: Lu AF35700 10 mg clinical formulation	Drug: Lu AF35700 10 mg clinical formulation; Lu AF35700 tablets 10 mg oral single dose
Experimental: Lu AF35700 10 mg commercial formulation	Drug: Lu AF35700 10 mg commercial formulation; Lu AF35700 tablets 10 mg oral single dose
Experimental: Lu AF35700 20 mg clinical formulation	Drug: Lu AF35700 20 mg clinical formulation; Lu AF35700 tablets 20 mg oral single dose
Experimental: Lu AF35700 20 mg commercial formulation	Drug: Lu AF35700 20 mg commercial formulation; Lu AF35700 tablets 20 mg oral single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax of Lu AF35700	Time to occurance of Cmax of Lu AF35700	zero to 72 hours
AUC0-t of Lu AF35700	Area under the Lu AF35700 concentration-time curve from zero to time of the last quantifiable plasma concentration	zero to time of the last quantifiable plasma concentration

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): October 5, 2018
• Study Completion (Actual): October 5, 2018

Study Registration Dates

• First Submitted: January 3, 2018
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 9, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 17481A; 2017-001335-39 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No