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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2021-12-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The first 3 periods will be randomized.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lu AG06466 Capsule, Fasted State

Participants will receive 1 capsule of Lu AG06466 in a fasted state.

Group Type EXPERIMENTAL

Lu AG06466 Capsule

Intervention Type DRUG

Hard capsule

Lu AG06466 Tablet, Fasted State

Participants will receive 1 tablet of Lu AG06466 in a fasted state.

Group Type EXPERIMENTAL

Lu AG06466 Tablet

Intervention Type DRUG

Film-coated tablet

Lu AG06466 Tablet, Fed State

Participants will receive 1 tablet of Lu AG06466 in a fed state (high-fat meal).

Group Type EXPERIMENTAL

Lu AG06466 Tablet

Intervention Type DRUG

Film-coated tablet

Lu AG06466 Tablet + Antacid, Fasted State

Participants will receive 1 tablet of Lu AG06466 dosed in combination with antacid in a fasted state.

Group Type EXPERIMENTAL

Lu AG06466 Tablet

Intervention Type DRUG

Film-coated tablet

Antacid

Intervention Type DRUG

Oral suspension

Interventions

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Lu AG06466 Capsule

Hard capsule

Intervention Type DRUG

Lu AG06466 Tablet

Film-coated tablet

Intervention Type DRUG

Antacid

Oral suspension

Intervention Type DRUG

Other Intervention Names

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Maalox Aluminum hydroxide and magnesium hydroxide

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes