A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04104503

Enrollment

Registered

2019-09-26

Start date

2019-09-17

Completion date

2020-04-09

Last updated

2020-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed description

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.

Interventions

DRUGLu AF11167

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

DRUG[14C]-Lu AF11167

single iv microdose administered as a 15 minutes infusion

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

Single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Cmax of Lu AF11167	From 0 to 48 hours	Maximum observed plasma concentration
AUC(0-inf) of Lu AF11167	From 0 to 48 hours	Area under the plasma concentration time curve from zero to infinity
Relative bioavailability F(rel) of Lu AF11167	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)
Absolute bioavailability F(abs) of Lu AF11167	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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026