Healthy
Conditions
Brief summary
The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other clinical trials. They will measure the levels of the drug in the bloodstream for up to 3 days after participants take either the tablet or the capsule formulation. They will also look at whether the tablet formulation behaves differently when it is taken with and without food.
Detailed description
This study will consist of 6 sequences with 4 periods (3 days/period) in each sequence. The first 3 periods will be randomized. Each Lu AG06466 dose administration will be separated by a washout period of at least 72 hours.
Interventions
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The first 3 periods will be randomized.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* The participant has a body mass index (BMI) ≥18.5 and ≤30 kg/m\^2 at the Screening Visit and at the Baseline Visit. * The participant is, in the opinion of the investigator, generally healthy based on medical history; a physical examination; vital signs; an electrocardiogram (ECG); and the results of the clinical chemistry, hematology, urinalysis, serology, and other laboratory tests at the Screening Visit and/or the Baseline Visit.
Exclusion criteria
* The participant has a personal history of a clinically significant psychiatric disorder (including severe affective disorder, severe anxiety disorder, psychotic tendencies, and drug-induced psychoses). * The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder. Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | AUC(0-inf) is defined as AUC0-tlast + Clast \* t1/2 / ln2 (where Clast is the last quantifiable concentration and t1/2 is the apparent elimination half-life). |
| AUC(0-inf) of Metabolite Lu AG06988 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | AUC(0-inf) is defined as AUC0-tlast + Clast \* t1/2 / ln2 (where Clast is the last quantifiable concentration and t1/2 is the apparent elimination half-life). |
| Area Under Plasma Concentration-Time Curve from Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AG06466 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | — |
| AUC0-tlast of Metabolite Lu AG06988 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | — |
| Maximum Observed Plasma Concentration (Cmax) of Lu AG06466 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | — |
| Cmax of Metabolite Lu AG06988 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | — |
| Time to Reach Cmax (Tmax) of Lu AG06466 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | — |
| Tmax of Metabolite Lu AG06988 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | — |
| Apparent Oral Clearance (CL/F) of Lu AG06466 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | CL/F is defined as dose / AUC0-inf. |
| Apparent Volume of Distribution (Vz/F) of Lu AG06466 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | Vz/F is defined as CL/F \* t1/2 / ln2. |
| Apparent Elimination Half-life (t1/2) of Lu AG06466 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | — |
| t1/2 of Metabolite Lu AG06988 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | — |
| Metabolic Ratio (MR) | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | MR is defined as AUC0-inf, Lu AG06988 / AUC0-inf, Lu AG06466. |
Countries
United Kingdom
Outcome results
None listed