Safety and Tolerability of Lu AF95245 in Healthy Young Men

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: Lu AF95245; Drug: Placebo; Drug: Lu AF95245 14C radiolabelled spiked dosage

• Registration Number: NCT04199585
• Lead Sponsor: H. Lundbeck A/S

Brief 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

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 Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-12
• Study First Posted: 2019-12-16
• Primary Completion: 2020-02-16
• Study Completion: 2020-02-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 18

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort A: single-ascending oral dose	Lu AF95245	Cohorts A1 to A6, single ascending dose, with 9 subjects in each cohort, sequential
Cohort A: single-ascending oral dose	Placebo	Cohorts A1 to A6, single ascending dose, with 9 subjects in each cohort, sequential
Cohort B: (fasting/fed conditions)	Lu AF95245	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
Cohort B: (fasting/fed conditions)	Lu AF95245 14C radiolabelled spiked dosage	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

Primary Outcome Measures

Name	Time	Method
Cmax Lu AF95245	From 0 to 96 hours	Maximum observed plasma concentration
Total recovery of the administered dose (% of dose in urine and faeces)	From 0 to Day 14	Excretion of labelled Lu AF95245 in urine and faeces
Number of participants with treatment-emergent adverse events	From baseline to Day 14	Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)
CL/F Lu AF95245	From 0 to 96 hours	Oral clearance for Lu AF95245 in plasma
AUC(0-inf) Lu AF95245	From 0 to 96 hours	Area under the plasma concentration time curve from zero to infinity

Trial Locations

Locations (1)

QPS Netherlands BV; 🇳🇱 Groningen, Netherlands