Single Ascending Dose Study of Lu AF76432 in Healthy Young Men

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Lu AF76432

• Registration Number: NCT03531229
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-17
• Study First Submitted: 2018-04-20
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Primary Completion: 2019-02-22
• Study Completion: 2019-02-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo to Lu AF76432
Lu AF76432	Lu AF76432	Lu AF76432

Primary Outcome Measures

Name	Time	Method
Number of participants with Treatment-Emergent Adverse Events	From dosing to 12 days	Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)

Secondary Outcome Measures

Name	Time	Method
Cmax	From dosing to 72 hours post dose	Maximum observed concentration
AUC0-inf	From dosing to 72 hours post dose	Area under the plasma concentration-time curve from zero to infinity
CL/F	From dosing to 72 hours post dose	Oral clearance
AUC0-t	From dosing to 72 hours post dose	Area under the plasma concentration-time curve from zero to time t

Trial Locations

Locations (1)

Parexel Early Phase Clinical Unit; 🇬🇧 Harrow, United Kingdom