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A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

NCT04104503 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-04-17

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DRUG

Lu 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

DRUG

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

Single oral dose

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-17
Primary Completion
2020-04-09
Completion
2020-04-09

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04104503 on ClinicalTrials.gov