NCT03565094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started May 2018

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2019

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

1.2 years

First QC Date

June 8, 2018

Last Update Submit

September 25, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • AUC 0-inf

    area under the plasma concentration-time curve of Lu AF28996

    From dosing to day 12 postdose

  • Cmax

    maximum observed plasma concentration of Lu AF28996

    From dosing to day 12 postdose

  • CL/F

    Oral clearance of Lu AF28996

    From dosing to day 12 postdose

Secondary Outcomes (1)

  • Number of participants with Treatment-Emergent Adverse Events

    From dosing to day 12 postdose

Study Arms (1)

Lu AF28996

EXPERIMENTAL

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)

Drug: Lu AF28996 solutionDrug: Lu AF28996 capsule

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
Lu AF28996 capsuleDRUG

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

Lu AF28996

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QPS Netherlands BV

Groningen, Netherlands

Location

Study Officials

  • Email contact via H. Lundbeck A/S

    LundbeckClinicalTrials@Lundbeck.com

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 21, 2018

Study Start

May 29, 2018

Primary Completion

August 17, 2019

Study Completion

August 21, 2019

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

NL(1)