Skip to main content
OpenTrials
Completed

NCT Number: NCT03565094

Single Dose of Lu AF28996 to Healthy Young Men

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

QPS Netherlands BV

Groningen, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lu AF28996 solution

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

Drug

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

Primary outcomes

  1. AUC 0-inf

    Time frame: From dosing to day 12 postdose

    area under the plasma concentration-time curve of Lu AF28996

  2. Cmax

    Time frame: From dosing to day 12 postdose

    maximum observed plasma concentration of Lu AF28996

  3. CL/F

    Time frame: From dosing to day 12 postdose

    Oral clearance of Lu AF28996

Secondary outcomes

  1. Number of participants with Treatment-Emergent Adverse Events

    Time frame: From dosing to day 12 postdose

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

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Interventional, Open-label, Single- and Sequential-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Profile of Lu AF28996 in Healthy Young Men

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2018
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.