A Study Investigating Tablet Formulations of Lu AF11167 in Healthy Subjects

NCT04104503 | Completed Phase 1

• 1 other identifier: 18153A
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the extent to which Lu AF11167 enters the bloodstream following tablet intake and the influence of food on uptake in healthy men and women

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Cmax of Lu AF11167

  Maximum observed plasma concentration

  From 0 to 48 hours

• AUC(0-inf) of Lu AF11167

  Area under the plasma concentration time curve from zero to infinity

  From 0 to 48 hours

• Relative bioavailability F(rel) of Lu AF11167

  F(rel) is estimated as the dose normalized AUC(inf) for the test formulation relative to the reference formulation (part A only)

  From 0 to 48 hours

• Absolute bioavailability F(abs) of Lu AF11167

  F(abs) is estimated as the dose normalized AUC(inf) for the test formulation relative to the intravenous reference formulation (part B only)

  From 0 to 48 hours

Study Arms (4)

Part A

EXPERIMENTAL

Drug: Lu AF11167

Part B group 1

EXPERIMENTAL

Treatment period 1: Fasted + iv; Treatment period 2: Fasted; Treatment period 3: High-fat meal

Drug: [14C]-Lu AF11167; Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)

Part B group 2

EXPERIMENTAL

Treatment period 1: High-fat meal; Treatment period 2: Fasted + iv; Treatment period 3: Fasted

Drug: [14C]-Lu AF11167; Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)

Part B group 3

EXPERIMENTAL

Treatment period 1: Fasted; Treatment period 2: High-fat meal; Treatment period 3: Fasted + iv

Drug: [14C]-Lu AF11167; Drug: Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)

Interventions

Lu AF11167 DRUG

Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations)

Part A

[14C]-Lu AF11167 DRUG

single iv microdose administered as a 15 minutes infusion

Part B group 1; Part B group 2; Part B group 3

Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation) DRUG

Single oral dose

Part B group 1; Part B group 2; Part B group 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index (BMI) of ≥18.5 and ≤30.0 kg/m2
• (Part B only) Women of child-bearing potential will have a confirmed non-pregnant and non-lactating status

You may not qualify if:

• The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the investigational medical product

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Quotient

Nottingham, United Kingdom

Location

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: September 17, 2019
• Primary Completion: April 9, 2020
• Study Completion: April 9, 2020
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

GB (1)