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Safety and Tolerability of Lu AG06479 in Healthy Young Men

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

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04473651
Enrollment
46
Registered
2020-07-16
Start date
2020-07-09
Completion date
2021-11-10
Last updated
2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Detailed description

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

Interventions

DRUGLu AG06479

capsules, orally (Part A and B)

DRUGPlacebos

Placebo - capsules, orally (Part A only)

Sponsors

H. Lundbeck A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with treatment emergent adverse events (Safety and Tolerability)From baseline to Day 9 (Part A and B)Based on the safety assessments (e.g. clinical safety laboratory tests, vital signs, weight and ECG parameters)

Secondary

MeasureTime frameDescription
AUC (0-inf) of Lu AG06479From pre-dose to Day 5 (Part A and B)Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf)
CL/F Lu AG06479From pre-dose to Day 5 (Part A and B)Oral clearance of Lu AG06479
Cmax Lu AG06479From pre-dose to Day 5 (Part A and B)Maximum observed plasma concentration for Lu AG06479

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026