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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lu AF35700; Drug: Lu AF35700 iv

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• 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 ≤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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Fasting condition in Period I; Subjects will be in fasting condition in Period I and in a fed condition in Period II.	Drug: Lu AF35700; 20 mg Lu AF35700 single oral dose; Drug: Lu AF35700 iv; 100 μg [14C]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose
Experimental: Group 2: Fed condition in Period I; Subjects will be in fed condition in Period I and in fasting condition in Period II.	Drug: Lu AF35700; 20 mg Lu AF35700 single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute bioavailability Fabs	Fabs= 100*(AUC0-72h, po*Div) / (AUC0-72h, iv*Dpo) (where D is the dose)	0 to 120 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cmax: maximum observed plasma concentration	Maximum observed plasma concentration of Lu AF35700	0 to 120 hours
tmax: time at maximum observed plasma concentration	Time at which maximum observed plasma concentration of Lu AF35700 occurred	0 to 120 hours

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): January 13, 2019

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 17482A

Drug and device information, study documents

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