Single Dose of Lu AF28996 to Healthy Young Men

• ClinicalTrials.gov Identifier: NCT03565094
• Recruitment Status: Completed
• First Posted: June 21, 2018
• Last Update Posted: September 26, 2019
• Sponsor: H. Lundbeck A/S
• Information provided by (Responsible Party): H. Lundbeck A/S

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Netherlands

QPS Netherlands BV

Groningen, Netherlands

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S; LundbeckClinicalTrials@Lundbeck.com

More Information

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

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

Additional relevant MeSH terms:

Pharmaceutical Solutions