Single Ascending Dose Study of Lu AF76432 in Healthy Young Men

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lu AF76432; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03531229

17479A

Details and patient eligibility

About

The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men

Enrollment: 42 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-Healthy young non-smoking men ≥18 years of age and ≤45 years of age at the Screening Visit and a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit.

Exclusion criteria

• The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder or the subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason
• The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP

Other inclusion and exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo to Lu AF76432

Treatment:

Drug: Placebo

Lu AF76432

Experimental group

Description:

Lu AF76432

Treatment:

Drug: Lu AF76432