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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lu AF35700; Drug: Lu AF35700 iv

• Registration Number: NCT03670082
• Lead Sponsor: H. Lundbeck A/S

Brief 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

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 Timeline

• Study Start: 2018-09-05
• Study First Submitted: 2018-09-12
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-13
• Primary Completion: 2018-12-21
• Study Completion: 2019-01-13
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1: Fasting condition in Period I	Lu AF35700	Subjects will be in fasting condition in Period I and in a fed condition in Period II.
Group 1: Fasting condition in Period I	Lu AF35700 iv	Subjects will be in fasting condition in Period I and in a fed condition in Period II.
Group 2: Fed condition in Period I	Lu AF35700	Subjects will be in fed condition in Period I and in fasting condition in Period II.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
tmax: time at maximum observed plasma concentration	0 to 120 hours	Time at which maximum observed plasma concentration of Lu AF35700 occurred
AUC0-inf: area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours	0 to 120 hours	Area under the plasma concentration-time curve from zero to 72 hours for Lu AF35700
Cmax: maximum observed plasma concentration	0 to 120 hours	Maximum observed plasma concentration of Lu AF35700

Trial Locations

Locations (1)

Covance; 🇬🇧 Leeds, United Kingdom