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A Study Investigating the Movement of Lu AF28996 Into, Through, and Out of the Body of Healthy Men

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Lundbeck

Status and phase

Completed
Phase 1

Conditions

Healthy Participants

Treatments

Drug: Lu AF28996

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

The main goal of this study is to learn about how Lu AF28996 moves into, through, and out of the body after a single dose is given to healthy male participants.

Enrollment

8 patients

Sex

Male

Ages

35 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • The participant has a Body Mass Index (BMI) >=18.5 and <=30 kilograms per square meter (kg/m^2) and body weight ≥60 kg at the Screening Visit and at the Baseline Visit.
  • The participant has a resting supine pulse >=50 and <=100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit.
  • The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Key Exclusion Criteria:

  • The participant has participated in a clinical trial <30 days prior to the Screening Visit.
  • The participant has taken any investigational medicinal product <3 months or <5 half-lives of that product, whichever is longest, prior to the first dose of investigational medicinal product (IMP).
  • Participants with exposure to significant diagnostic or therapeutic radiation (eg, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.

Other protocol-defined criteria apply.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

8 participants in 1 patient group

Lu AF28996
Experimental group
Description:
Participants will receive a single oral dose of Lu AF28996.
Treatment:
Drug: Lu AF28996

Trial contacts and locations

1

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Central trial contact

Email contact via H. Lundbeck A/S

Data sourced from clinicaltrials.gov

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