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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. Identifier: NCT03565094
Recruitment Status : Completed
First Posted : June 21, 2018
Last Update Posted : September 26, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Lu AF28996 solution Drug: Lu AF28996 capsule Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interventional, Open-label, Single- and Sequential-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic Profile of Lu AF28996 in Healthy Young Men
Actual Study Start Date : May 29, 2018
Actual Primary Completion Date : August 17, 2019
Actual Study Completion Date : August 21, 2019

Arm Intervention/treatment
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)

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

Primary Outcome Measures :
  1. AUC 0-inf [ Time Frame: From dosing to day 12 postdose ]
    area under the plasma concentration-time curve of Lu AF28996

  2. Cmax [ Time Frame: From dosing to day 12 postdose ]
    maximum observed plasma concentration of Lu AF28996

  3. CL/F [ Time Frame: From dosing to day 12 postdose ]
    Oral clearance of Lu AF28996

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT03565094

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QPS Netherlands BV
Groningen, Netherlands
Sponsors and Collaborators
H. Lundbeck A/S
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Study Director: Email contact via H. Lundbeck A/S

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Responsible Party: H. Lundbeck A/S Identifier: NCT03565094     History of Changes
Other Study ID Numbers: 17695A
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pharmaceutical Solutions