Safety and Tolerability of Lu AF95245 in Healthy Young Men

NCT ID: NCT04199585

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2020-02-19

Brief Summary

The purpose of this study is to investigate the safety and tolerability of Lu AF95245 and what the body does to Lu AF95245 after swallowing single doses of the drug

Detailed Description

The study is divided in two parts, Part A and Part B:

Part A: interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending oral dose study in healthy young men.

Part A will consist of up to 6 cohorts (Cohorts A1 to A6) with 9 subjects in each cohort. In each cohort, the subjects will be randomised to receive a single oral dose of Lu AF95245 or placebo (ratio 6:3)

Part B: interventional, randomized, open-label, three-period crossover study to investigate intra-subject variability, effect of food and mass balance and metabolic profile in healthy young men. Part B will be initiated when a anticipated therapeutically relevant dose confirmed to be safe and well-tolerated has been identified in Part A; this dose will be used in Part B. Part B is divided into 3 dosing periods and subjects will be randomised to 1 of 3 groups (Groups B1, B2, and B3) with 4 subjects in each group and the groups will be running in parallel.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort A: single-ascending oral dose

Cohorts A1 to A6, single ascending dose, with 9 subjects in each cohort, sequential

Group Type: EXPERIMENTAL

Lu AF95245

Intervention Type: DRUG

solution, single dose, orally

Placebo

Intervention Type: DRUG

solution, single dose, orally

Cohort B: (fasting/fed conditions)

Groups B1, B2, and B3, with 4 subjects in each group and the groups will be running in parallel.

B1: fed-fasting-fasting condition (spiked dosage)

B2: fasting-fed-fasting condition (spiked dosage)

B3: fasting-fasting-fed condition

Group Type: EXPERIMENTAL

Lu AF95245

Intervention Type: DRUG

solution, single dose, orally

Lu AF95245 14C radiolabelled spiked dosage

Intervention Type: DRUG

solution, single dose, orally

Interventions

Lu AF95245

solution, single dose, orally

Intervention Type: DRUG

Lu AF95245 14C radiolabelled spiked dosage

solution, single dose, orally

Intervention Type: DRUG

Placebo

solution, single dose, orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy, young, non-smoking men with a body mass index (BMI) ≥18.5 kg/m2 and ≤30 kg/m2 at the Screening Visit.

Exclusion Criteria

• The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

QPS Netherlands BV

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

18193A

Identifier Type: -

Identifier Source: org_study_id