Single Ascending Dose Study of Lu AF76432 in Healthy Young Men

Healthy Clinical Trial

Official title:

Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-oral-dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF76432 in Healthy Young Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531229
• Other study ID #: 17479A
• Status: Completed
• Phase: Phase 1
• Start date: April 17, 2018
• Est. completion date: February 22, 2019

Study information

• Verified date: April 2019
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 22, 2019
• Est. primary completion date: February 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Placebo
Placebo to Lu AF76432 oral solution
• Lu AF76432
Lu AF76432 oral solution 2.5 mg/ml. Starting dose will be 3,5 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).

Locations

Country	Name	City	State
United Kingdom	Parexel Early Phase Clinical Unit	Harrow

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Treatment-Emergent Adverse Events	Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)	From dosing to 12 days
Secondary	AUC0-t	Area under the plasma concentration-time curve from zero to time t	From dosing to 72 hours post dose
Secondary	Cmax	Maximum observed concentration	From dosing to 72 hours post dose
Secondary	AUC0-inf	Area under the plasma concentration-time curve from zero to infinity	From dosing to 72 hours post dose
Secondary	CL/F	Oral clearance	From dosing to 72 hours post dose