Clinical trial NCT05028673: A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants
Official title: Interventional, Randomized, Open-Label, Crossover, Single-Dose, Relative Bioavailability Study Comparing Two Pharmaceutical Formulations of Lu AG06466 and Investigating the Food Effect on Lu AG06466 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-08-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The first 3 periods will be randomized.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 exclusion criteria may apply.

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: AUC(0-inf) of Metabolite Lu AG06988
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: Area Under Plasma Concentration-Time Curve from Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AG06466
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: AUC0-tlast of Metabolite Lu AG06988
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: Maximum Observed Plasma Concentration (Cmax) of Lu AG06466
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: Cmax of Metabolite Lu AG06988
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: Time to Reach Cmax (Tmax) of Lu AG06466
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: Tmax of Metabolite Lu AG06988
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: Apparent Oral Clearance (CL/F) of Lu AG06466
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: Apparent Volume of Distribution (Vz/F) of Lu AG06466
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: Apparent Elimination Half-life (t1/2) of Lu AG06466
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: t1/2 of Metabolite Lu AG06988
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
measure: Metabolic Ratio (MR)
timeFrame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: LabCorp Clinical Research Unit Ltd
Study officials:
References: