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

H. Lundbeck A/S10 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Lu AF35700DRUG

20 mg Lu AF35700 single oral dose

Lu AF35700 ivDRUG

100 μg \[14C\]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Covance

Leeds, United Kingdom

Outcomes

Primary Outcomes

Absolute bioavailability Fabs

Fabs= 100\*(AUC0-72h, po\*Div) / (AUC0-72h, iv\*Dpo) (where D is the dose)

Time frame: 0 to 120 hours

Secondary Outcomes

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

Time frame: 0 to 120 hours

Cmax: maximum observed plasma concentration

Maximum observed plasma concentration of Lu AF35700

Time frame: 0 to 120 hours

tmax: time at maximum observed plasma concentration

Time at which maximum observed plasma concentration of Lu AF35700 occurred

Time frame: 0 to 120 hours

Data from ClinicalTrials.gov

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