Safety and Tolerability of Lu AF95245 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 AF95245 and Open-label Crossover Study to Investigate Intra-subject Variability, Effect of Food on Lu AF95245, and Metabolic Profile of [14C]-Lu AF95245 in Healthy Young Men

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04199585
• Other study ID #: 18193A
• Status: Terminated
• Phase: Phase 1
• Start date: December 10, 2019
• Est. completion date: February 19, 2020

Study information

• Verified date: May 2020
• 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 the safety and tolerability of Lu AF95245 and what the body does to Lu AF95245 after swallowing single doses of the drug

Description:

The study is divided in two parts, Part A and Part B:

Part A: interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending oral dose study in healthy young men.

Part A will consist of up to 6 cohorts (Cohorts A1 to A6) with 9 subjects in each cohort. In each cohort, the subjects will be randomised to receive a single oral dose of Lu AF95245 or placebo (ratio 6:3)

Part B: interventional, randomized, open-label, three-period crossover study to investigate intra-subject variability, effect of food and mass balance and metabolic profile in healthy young men. Part B will be initiated when a anticipated therapeutically relevant dose confirmed to be safe and well-tolerated has been identified in Part A; this dose will be used in Part B. Part B is divided into 3 dosing periods and subjects will be randomised to 1 of 3 groups (Groups B1, B2, and B3) with 4 subjects in each group and the groups will be running in parallel.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: February 19, 2020
• Est. primary completion date: February 16, 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) =18.5 kg/m2 and =30 kg/m2 at the Screening Visit.

Exclusion Criteria:

• The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP.

Other in- and exclusion criteria may apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lu AF95245
solution, single dose, orally
• Lu AF95245 14C radiolabelled spiked dosage
solution, single dose, orally
• Placebo
solution, single dose, orally

Locations

Country	Name	City	State
Netherlands	QPS Netherlands BV	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 and physical examination)	From baseline to Day 14
Primary	AUC(0-inf) Lu AF95245	Area under the plasma concentration time curve from zero to infinity	From 0 to 96 hours
Primary	Cmax Lu AF95245	Maximum observed plasma concentration	From 0 to 96 hours
Primary	CL/F Lu AF95245	Oral clearance for Lu AF95245 in plasma	From 0 to 96 hours
Primary	Total recovery of the administered dose (% of dose in urine and faeces)	Excretion of labelled Lu AF95245 in urine and faeces	From 0 to Day 14