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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lu AF35700
* Drug: Lu AF35700 iv


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |