Single Dose of Lu AF28996 to Healthy Young Men

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lu AF28996 solution; Drug: Lu AF28996 capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03565094

17695A

Details and patient eligibility

About

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

Full description

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

Enrollment: 39 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Lu AF28996

Experimental group

Description:

Lu AF28996 solution, cohort depending dose Part A: Cohort 1: single oral dose of Lu AF28996 Cohorts 2-6: two single ascending oral doses of Lu AF28996 with a washout in between Possibility of 4 additional cohorts (Cohorts 7 to 10), allowing for the investigation of a potential 13 additional subjects Part B: 8 subjects (randomised to one of four treatment sequences)

Treatment:

Drug: Lu AF28996 solution

Drug: Lu AF28996 capsule