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Trial record 1 of 1 for:    Lu AF28996
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Single Dose of Lu AF28996 to 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: NCT03565094
Recruitment Status : Completed
First Posted : June 21, 2018
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE June 8, 2018
First Posted Date  ICMJE June 21, 2018
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE May 29, 2018
Actual Primary Completion Date August 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
  • AUC 0-inf [ Time Frame: From dosing to day 12 postdose ]
    area under the plasma concentration-time curve of Lu AF28996
  • Cmax [ Time Frame: From dosing to day 12 postdose ]
    maximum observed plasma concentration of Lu AF28996
  • CL/F [ Time Frame: From dosing to day 12 postdose ]
    Oral clearance of Lu AF28996
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03565094 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
Number of participants with Treatment-Emergent Adverse Events [ Time Frame: From dosing to day 12 postdose ]
Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight and ECG parameters)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Dose of Lu AF28996 to Healthy Young Men
Official Title  ICMJE Interventional, Open-label, Single- and Sequential-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Profile of Lu AF28996 in Healthy Young Men
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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

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

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)

Interventions:
  • Drug: Lu AF28996 solution
  • Drug: Lu AF28996 capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 30, 2019)
39
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2018)
18
Actual Study Completion Date  ICMJE August 21, 2019
Actual Primary Completion Date August 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03565094
Other Study ID Numbers  ICMJE 17695A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP