Single Dose of Lu AF28996 to Healthy Young Men

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Lu AF28996 solution; Drug: Lu AF28996 capsule

• Registration Number: NCT03565094
• Lead Sponsor: H. Lundbeck A/S

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

Study Timeline

• Study Start: 2018-05-29
• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-21
• Primary Completion: 2019-08-17
• Study Completion: 2019-08-21
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-25
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lu AF28996	Lu AF28996 solution	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)
Lu AF28996	Lu AF28996 capsule	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)

Primary Outcome Measures

Name	Time	Method
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
AUC 0-inf	From dosing to day 12 postdose	area under the plasma concentration-time curve of Lu AF28996

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

QPS Netherlands BV; 🇳🇱 Groningen, Netherlands