Single Dose of Lu AF28996 to Healthy Young Men

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565094
• Other study ID #: 17695A
• Status: Completed
• Phase: Phase 1
• Start date: May 29, 2018
• Est. completion date: August 21, 2019

Study information

• Verified date: September 2019
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 21, 2019
• Est. primary completion date: August 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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
• Lu AF28996 capsule
hard capsule orally QD: one dose lower than the highest dose level in part A

Locations

Country	Name	City	State
Netherlands	QPS Netherlands BV	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC 0-inf	area under the plasma concentration-time curve of Lu AF28996	From dosing to day 12 postdose
Primary	Cmax	maximum observed plasma concentration of Lu AF28996	From dosing to day 12 postdose
Primary	CL/F	Oral clearance of Lu AF28996	From dosing to day 12 postdose
Secondary	Number of participants with Treatment-Emergent Adverse Events	Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight and ECG parameters)	From dosing to day 12 postdose