Single Dose of Lu AF28996 to Healthy Young Men

H. Lundbeck A/S39 enrolled

Overview

This study evaluates how increasing doses of Lu AF28996 enters, moves through and exits the body when given by mouth to healthy young men.

Part A of the study consists of 6 groups (Cohorts 1 to 6) with 3 subjects in each, with the possibility of 4 additional cohorts. In cohort 1, the subjects will receive a single dose of Lu AF28996 by mouth. Following evaluation of data from the first dose, the subjects in the following cohorts are planned to receive two single increasing doses by mouth of Lu AF28996 on 2 separate days with a wash out (day or days without dosing) in between. Part B is an open-label three-period crossover study in healthy young men to compare the PK of an oral capsule formulation with that of an oral solution formulation and to evaluate food effect following oral capsule administration of Lu AF28996.The subjects will be randomised to one of the four treatment sequences

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Lu AF28996 solutionDRUG

Oral solution (0.1-0.2 mg/mL) Following each cohort, a dosing conference will be held where tolerability, safety and preliminary PK results from the previous cohorts will be reviewed before deciding on the next doses

Lu AF28996 capsuleDRUG

hard capsule orally QD: one dose lower than the highest dose level in part A

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criterium: Healthy, young, non-smoking men aged ≥18 and ≤45 years and with a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit Other in- and exclusion criteria may apply

Locations (1)

QPS Netherlands BV

Groningen, Netherlands

Outcomes

Primary Outcomes

AUC 0-inf

area under the plasma concentration-time curve of Lu AF28996

Time frame: From dosing to day 12 postdose

Cmax

maximum observed plasma concentration of Lu AF28996

Time frame: From dosing to day 12 postdose

CL/F

Oral clearance of Lu AF28996

Time frame: From dosing to day 12 postdose

Secondary Outcomes

Number of participants with Treatment-Emergent Adverse Events

Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight and ECG parameters)

Time frame: From dosing to day 12 postdose

Data from ClinicalTrials.gov

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