Single Dose of Lu AF28996 to Healthy Young Men

NCT ID: NCT03565094

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-29
• Study Completion Date: 2019-08-21

Brief Summary

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

Detailed 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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lu AF28996

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)

Group Type: EXPERIMENTAL

Lu AF28996 solution

Intervention Type: DRUG

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 capsule

Intervention Type: DRUG

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

Interventions

Lu AF28996 solution

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

Intervention Type: DRUG

Lu AF28996 capsule

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

QPS Netherlands BV

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

17695A

Identifier Type: -

Identifier Source: org_study_id