Bioequivalence Study of Lu AF35700

Healthy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394482
• Other study ID #: 17481A
• Secondary ID: 2017-001335-39
• Status: Completed
• Phase: Phase 1
• Start date: January 3, 2018
• Est. completion date: October 5, 2018

Study information

• Verified date: November 2018
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 5, 2018
• Est. primary completion date: October 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Covance	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cmax of Lu AF35700	Maximum observed plasma concentration (Cmax) of Lu AF35700	zero to 72 hours
Secondary	Tmax of Lu AF35700	Time to occurance of Cmax of Lu AF35700	zero to 72 hours
Secondary	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