Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT04473651
  4. Details
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)
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1