Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State

Healthy Clinical Trial

Official title:

Interventional, Open-label, Two-way Crossover, Single-dose Study Investigating the Absolute Bioavailability and Food Effect on the Pharmacokinetics of Lu AF35700 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670082
• Other study ID #: 17482A
• Status: Completed
• Phase: Phase 1
• Start date: September 5, 2018
• Est. completion date: January 13, 2019

Study information

• Verified date: October 2019
• 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 investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women

Description:

Each subject will receive a single oral dose of Lu AF35700 on Day 1 in each Period. Subjects in Group 1 will be in fasting condition in Period I and in a fed condition in Period II. Subjects in Group 2 will be in fed condition in Period I and in fasting condition in Period II.

For Group 1, period 1 only, a single intravenous micro-dose of Lu AF35700 will be given 4 hours after oral dosing.

All subjects will be confined to the clinic from one day prior to the first dosing until Day 6 (120 hours post dose) for each dosing period. Periods I and II will be separated by a period of 6 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 13, 2019
• Est. primary completion date: December 21, 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 =30 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 metabolizer

Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lu AF35700
20 mg Lu AF35700 single oral dose
• Lu AF35700 iv
100 µg [14C]-Lu AF35700 (4.7 µCi/174 kBq) single intravenous micro-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	Absolute bioavailability Fabs	Fabs= 100*(AUC0-72h, po*Div) / (AUC0-72h, iv*Dpo) (where D is the dose)	0 to 120 hours
Secondary	AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours	Area under the plasma concentration-time curve from zero to 72 hours for Lu AF35700	0 to 120 hours
Secondary	Cmax: maximum observed plasma concentration	Maximum observed plasma concentration of Lu AF35700	0 to 120 hours
Secondary	tmax: time at maximum observed plasma concentration	Time at which maximum observed plasma concentration of Lu AF35700 occurred	0 to 120 hours