Safety and Tolerability of Lu AF95245 in Healthy Young Men

Lundbeck

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Lu AF95245; Drug: Placebo; Drug: Lu AF95245 14C radiolabelled spiked dosage

Study type: Interventional

Funder types: Industry

Identifiers

NCT04199585

18193A

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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18 participants in 2 patient groups

Cohort A: single-ascending oral dose

Experimental group

Description:

Cohorts A1 to A6, single ascending dose, with 9 subjects in each cohort, sequential

Treatment:

Drug: Lu AF95245

Drug: Placebo

Cohort B: (fasting/fed conditions)

Experimental group

Description:

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

Treatment:

Drug: Lu AF95245

Drug: Lu AF95245 14C radiolabelled spiked dosage