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NCT04473651 Clinical Trial

Safety and Tolerability of Lu AG06479 in Healthy Young Men

Healthy Clinical Trial

Official title:
Interventional, Randomized, Double-blind, Placebo-controlled, Sequential-group, Single-ascending Oral Dose Study Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06479 and Open-label Cross-over Study to Investigate Intra-subject Variability and Effect of Food in Healthy Young Men

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04473651
Other study ID # 18452A
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date July 9, 2020
Est. completion date November 10, 2021

Study information
Verified date November 2021
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and tolerability of Lu AG06479 and what the body does to Lu AG06479 after swallowing single doses of the drug.

Description:

Part A: randomized, sequential Part B: open-label, cross-over

Recruitment information / eligibility
Status Terminated
Enrollment 46
Est. completion date November 10, 2021
Est. primary completion date November 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Healthy, young, non-smoking men, weight =60 kg, and a body mass index (BMI) =18.5 kg/m2 and =30 kg/m2 at the Screening Visit. Other in- and exclusion criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lu AG06479
capsules, orally (Part A and B)
• Placebos
Placebo - capsules, orally (Part A only)

Locations
Country Name City State
United States Covance Madison Wisconsin

Sponsors (1)
Lead Sponsor Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with treatment emergent adverse events (Safety and Tolerability) Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters) From baseline to Day 9 (Part A and B)
Secondary AUC (0-inf) of Lu AG06479 Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf) From pre-dose to Day 5 (Part A and B)
Secondary CL/F Lu AG06479 Oral clearance of Lu AG06479 From pre-dose to Day 5 (Part A and B)
Secondary Cmax Lu AG06479 Maximum observed plasma concentration for Lu AG06479 From pre-dose to Day 5 (Part A and B)
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