Single Ascending Dose Study of Lu AF76432 in Healthy Young Men

• Sponsor: H. Lundbeck A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03531229
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.2
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate safety, tolerability and pharmacokinetics of the drug Lu AF76432 given as single oral ascending doses to healthy young men

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo; Drug: Lu AF76432	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: 36 Subjects are planned for enrolment, with 6 subjects per cohort. The subjects will be randomized to Lu AF76432 or placebo in a 4:2 ratio per cohort. A maximum of 2 additional cohorts of young healthy men will be permitted thereby allowing investigation of a maximum of 48 subjects36 Subjects are planned for enrolment, with 6 subjects per cohort. The subjects will be randomized to Lu AF76432 or placebo in a 4:2 ratio per cohort. A maximum of 2 additional cohorts of young healthy men will be permitted thereby allowing investigation of a maximum of 48 subjects
• 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 AF76432 in Healthy Young Men
• Actual Study Start Date: Apr 17, 2018
• Actual Primary Completion Date: Feb 22, 2019
• Actual Study Completion Date: Feb 22, 2019

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo to Lu AF76432	Drug: Placebo; Placebo to Lu AF76432 oral solution
Experimental: Lu AF76432 Lu AF76432	Drug: Lu AF76432; Lu AF76432 oral solution 2.5 mg/ml. Starting dose will be 3,5 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).

Outcome Measures

Primary Outcome Measures

1. Number of participants with Treatment-Emergent Adverse Events [From dosing to 12 days]

   Safety and Tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, weight, ECG parameters and physical examination)

Secondary Outcome Measures

1. AUC0-t [From dosing to 72 hours post dose]

   Area under the plasma concentration-time curve from zero to time t

2. Cmax [From dosing to 72 hours post dose]

   Maximum observed concentration

3. AUC0-inf [From dosing to 72 hours post dose]

   Area under the plasma concentration-time curve from zero to infinity

4. CL/F [From dosing to 72 hours post dose]

   Oral clearance

Eligibility Criteria

Criteria

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

Inclusion Criteria:

-Healthy young non-smoking men ≥18 years of age and ≤45 years of age at the Screening Visit and a body mass index (BMI) ≥18.5kg/m2 and ≤30kg/m2 at the Screening Visit.

Exclusion Criteria:

• The subject has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder or the subject is, in the opinion of the investigator, unlikely to comply with the protocol or is unsuitable for any reason

• The subject has taken any investigational medicinal product <3 months prior to the first dose of IMP

Other inclusion and exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parexel Early Phase Clinical Unit	Harrow		United Kingdom

Sponsors and Collaborators

• H. Lundbeck A/S

Investigators

• Study Director: Email contact via H. Lundbeck A/S, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Lundbeck A/S
• ClinicalTrials.gov Identifier: NCT03531229
• Other Study ID Numbers: 17479A
• First Posted: May 21, 2018
• Last Update Posted: Apr 12, 2019
• Last Verified: Apr 1, 2019

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

Study Results

No Results Posted as of Apr 12, 2019