NCT03670082

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-09-05
• Primary completion: 2018-12-21
• Completion: 2019-01-13
• First posted: 2018-09-13
• Last updated: 2019-11-01

Locations

1 site across 1 country: United Kingdom