Safety and Tolerability of Lu AG06479 in Healthy Young Men
- Registration Number
- NCT04473651
- Lead Sponsor
- H. Lundbeck A/S
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 46
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
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Single dose of Lu AG06479 or Placebo Lu AG06479 - Part B: Repeated dose of Lu AG06479 and Food interaction Lu AG06479 Sequence B1: Fed - Fasting - Fasting Sequence B2: Fasting- Fed - Fasting Sequence B3: Fasting- Fasting - Fed Part A: Single dose of Lu AG06479 or Placebo Placebos -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method CL/F Lu AG06479 From pre-dose to Day 5 (Part A and B) Oral clearance of Lu AG06479
AUC (0-inf) of Lu AG06479 From pre-dose to Day 5 (Part A and B) Area under the Lu AG06479 concentration-time curve from time zero to infinity (AUC0-inf)
Cmax Lu AG06479 From pre-dose to Day 5 (Part A and B) Maximum observed plasma concentration for Lu AG06479
Trial Locations
- Locations (1)
Covance
🇺🇸Madison, Wisconsin, United States