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NCT Number: NCT04104503

A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient

Nottingham, United Kingdom

About this study

This study will be split into Part A and Part B. Part A will happen first and will look at new tablet formulations of the test medicine compared to a previously known formulation (reference tablet). The results from Part A of the study will be used to decide which formulation will be tested in Part B of the study. Part B of the study will look at the food effect, variability between participants, and absolute bioavailability of the test medicine i.e. how much of the test medicine is taken up by the body when dosed by mouth compared to when dosed once by injection directly into the vein. Safety and tolerability will be assessed throughout the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) of ≥18.5 and ≤30.0 kg/m2
  • (Part B only) Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status

Exclusion criteria

  • The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the investigational medical product

Other in- and exclusion criteria may apply

Treatment and study plan

Lu AF11167

Drug

Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations)

[14C]-Lu AF11167

Drug

single iv microdose administered as a 15 minutes infusion

Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)

Drug

Single oral dose

Primary outcomes

  1. Cmax of Lu AF11167

    Time frame: From 0 to 48 hours

    Maximum observed plasma concentration

  2. AUC(0-inf) of Lu AF11167

    Time frame: From 0 to 48 hours

    Area under the plasma concentration time curve from zero to infinity

  3. Relative bioavailability F(rel) of Lu AF11167

    Time frame: From 0 to 48 hours

    F(rel) is estimated as the dose normalized AUC(inf) for the test formulation relative to the reference formulation (part A only)

  4. Absolute bioavailability F(abs) of Lu AF11167

    Time frame: From 0 to 48 hours

    F(abs) is estimated as the dose normalized AUC(inf) for the test formulation relative to the intravenous reference formulation (part B only)

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, Two-part, Partly-randomized Study Investigating the Pharmacokinetic Properties, Absolute Bioavailability, Food Effect, and Intra-subject Variability of up to 5 Prototype Modified-release Tablet Formulations of Lu AF11167 in Healthy Subjects

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2019
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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