Study Investigating the Safety and Tolerability of Lu AF88434 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 AF88434 and Open-label Crossover Study to Investigate the Intra-individual Variability, Metabolic Profile, and Effect of Food on Lu AF88434 in Healthy Young Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082325
• Other study ID #: 18144A
• Status: Completed
• Phase: Phase 1
• Start date: July 23, 2019
• Est. completion date: September 24, 2020

Study information

• Verified date: February 2021
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of Lu AF88434 on the body and what the body does to Lu AF88434 and the effect of food after swallowing single oral doses

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 24, 2020
• Est. primary completion date: September 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

-Healthy young non-smoking men with a body mass index (BMI) =18.5kg/m2 and =30kg/m2 at the Screening Visit and Baseline 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.

• For Part B: The subject has received radiolabelled material <12 months prior to the Screening Visit.

Other inclusion and exclusion criteria may apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lu AF88434
Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).
• Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
Oral solution
• Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)
Oral solution
• Placebo
Placebo to Lu AF88434 oral solution, single dose

Locations

Country	Name	City	State
Netherlands	QPS	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Netherlands, 

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)	From screening to Day 11
Primary	Cmax Lu AF88434	Maximum observed plasma concentration	From 0 to 96 hours
Primary	AUC(0-inf) Lu AF88434	Area under the plasma concentration time curve from zero to infinity	From 0 to 96 hours
Primary	CL/F Lu AF88434	Oral clearance for Lu AF88434 in plasma	From day 1 to day 5
Primary	Cumulative recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)		From 0 to Day 14
Primary	Total recovery of radioactivity in urine, faeces, and total (urine+faeces) (% of administered dose)		From 0 to Day 14