Safety and Tolerability of Lu AF95245 in Healthy Young Men

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

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

Study Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Drug: Lu AF95245; Drug: Placebo; Drug: Lu AF95245 14C radiolabelled spiked dosage

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • QPS Netherlands BV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A: single-ascending oral dose; Cohorts A1 to A6, single ascending dose, with 9 subjects in each cohort, sequential	Drug: Lu AF95245; solution, single dose, orally; Drug: Placebo; solution, single dose, orally
Experimental: Cohort B: (fasting/fed conditions); Groups B1, B2, and B3, with 4 subjects in each group and the groups will be running in parallel. B1: fed-fasting-fasting condition (spiked dosage) B2: fasting-fed-fasting condition (spiked dosage) B3: fasting-fasting-fed condition	Drug: Lu AF95245; solution, single dose, orally; Drug: Lu AF95245 14C radiolabelled spiked dosage; solution, single dose, orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
AUC(0-inf) Lu AF95245	Area under the plasma concentration time curve from zero to infinity	From 0 to 96 hours
Cmax Lu AF95245	Maximum observed plasma concentration	From 0 to 96 hours
CL/F Lu AF95245	Oral clearance for Lu AF95245 in plasma	From 0 to 96 hours
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

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): February 16, 2020
• Study Completion (Actual): February 19, 2020

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 18193A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No