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Safety and Tolerability of Lu AF95245 in Healthy Young Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04199585
Recruitment Status : Terminated (new safety data from another study)
First Posted : December 16, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Lu AF95245 Drug: Lu AF95245 14C radiolabelled spiked dosage Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Cohort A: sequential, cohort B parallel
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Lu AF95245 and Open-label Crossover Study to Investigate Intra-subject Variability, Effect of Food on Lu AF95245, and Metabolic Profile of [14C]-Lu AF95245 in Healthy Young Men
Actual Study Start Date : December 10, 2019
Actual Primary Completion Date : February 16, 2020
Actual Study Completion Date : February 19, 2020

Arm Intervention/treatment
Experimental: Cohort A: single-ascending oral dose
Cohorts A1 to A6, single ascending dose, with 9 subjects in each cohort, sequential
Drug: Lu AF95245
solution, single dose, orally

Drug: Placebo
solution, single dose, orally

Experimental: 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

Drug: Lu AF95245
solution, single dose, orally

Drug: Lu AF95245 14C radiolabelled spiked dosage
solution, single dose, orally




Primary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events [ Time Frame: From baseline to Day 14 ]
    Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)

  2. AUC(0-inf) Lu AF95245 [ Time Frame: From 0 to 96 hours ]
    Area under the plasma concentration time curve from zero to infinity

  3. Cmax Lu AF95245 [ Time Frame: From 0 to 96 hours ]
    Maximum observed plasma concentration

  4. CL/F Lu AF95245 [ Time Frame: From 0 to 96 hours ]
    Oral clearance for Lu AF95245 in plasma

  5. Total recovery of the administered dose (% of dose in urine and faeces) [ Time Frame: From 0 to Day 14 ]
    Excretion of labelled Lu AF95245 in urine and faeces



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Other in- and exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04199585


Locations
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Netherlands
QPS Netherlands BV
Groningen, Netherlands
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT04199585    
Other Study ID Numbers: 18193A
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No