A Study to Evaluate a New Tablet Formulation of Lu AG06466 in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Lu AG06466 Capsule; Drug: Lu AG06466 Tablet; Drug: Antacid

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • LabCorp Clinical Research Unit Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lu AG06466 Capsule, Fasted State; Participants will receive 1 capsule of Lu AG06466 in a fasted state.	Drug: Lu AG06466 Capsule; Hard capsule
EXPERIMENTAL: Lu AG06466 Tablet, Fasted State; Participants will receive 1 tablet of Lu AG06466 in a fasted state.	Drug: Lu AG06466 Tablet; Film-coated tablet
EXPERIMENTAL: Lu AG06466 Tablet, Fed State; Participants will receive 1 tablet of Lu AG06466 in a fed state (high-fat meal).	Drug: Lu AG06466 Tablet; Film-coated tablet
EXPERIMENTAL: Lu AG06466 Tablet + Antacid, Fasted State; Participants will receive 1 tablet of Lu AG06466 dosed in combination with antacid in a fasted state.	Drug: Lu AG06466 Tablet; Film-coated tablet; Drug: Antacid; Oral suspension; Other Names: Maalox; Aluminum hydroxide and magnesium hydroxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466	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).	0 (predose) up to 72 hours postdose on Day 1 to Day 12
AUC(0-inf) of Metabolite Lu AG06988	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).	0 (predose) up to 72 hours postdose on Day 1 to Day 12
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	CL/F is defined as dose / AUC0-inf.	0 (predose) up to 72 hours postdose on Day 1 to Day 12
Apparent Volume of Distribution (Vz/F) of Lu AG06466	Vz/F is defined as CL/F * t1/2 / ln2.	0 (predose) up to 72 hours postdose on Day 1 to Day 12
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)	MR is defined as AUC0-inf, Lu AG06988 / AUC0-inf, Lu AG06466.	0 (predose) up to 72 hours postdose on Day 1 to Day 12

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 23, 2021
• Primary Completion (ACTUAL): December 29, 2021
• Study Completion (ACTUAL): December 29, 2021

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (ACTUAL): August 31, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 20, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Gastrointestinal Agents; Adjuvants, Immunologic; Magnesium Hydroxide; Antacids; Aluminum Hydroxide
• Other Study ID Numbers: 19270A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No