Single Dose of Lu AF28996 to Healthy Young Men

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03565094

Enrollment

Registered

2018-06-21

Start date

2018-05-29

Completion date

2019-08-21

Last updated

2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGLu 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

DRUGLu AF28996 capsule

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
AUC 0-inf	From dosing to day 12 postdose	area under the plasma concentration-time curve of Lu AF28996
Cmax	From dosing to day 12 postdose	maximum observed plasma concentration of Lu AF28996
CL/F	From dosing to day 12 postdose	Oral clearance of Lu AF28996

Secondary

Measure	Time frame	Description
Number of participants with Treatment-Emergent Adverse Events	From dosing to day 12 postdose	Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight and ECG parameters)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026