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OpenTrials
Completed

NCT Number: NCT05028673

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

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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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

LabCorp Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AG06466 Capsule

Drug

Hard capsule

Lu AG06466 Tablet

Drug

Film-coated tablet

antacid

Drug

Oral suspension

Other names: Maalox, Aluminum hydroxide and magnesium hydroxide

Primary outcomes

  1. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466

    Time frame: 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).

  2. AUC(0-inf) of Metabolite Lu AG06988

    Time frame: 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).

  3. Area Under Plasma Concentration-Time Curve from Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AG06466

    Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12

  4. AUC0-tlast of Metabolite Lu AG06988

    Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12

  5. Maximum Observed Plasma Concentration (Cmax) of Lu AG06466

    Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12

  6. Cmax of Metabolite Lu AG06988

    Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12

  7. Time to Reach Cmax (Tmax) of Lu AG06466

    Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12

  8. Tmax of Metabolite Lu AG06988

    Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12

  9. Apparent Oral Clearance (CL/F) of Lu AG06466

    Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12

    CL/F is defined as dose / AUC0-inf.

  10. Apparent Volume of Distribution (Vz/F) of Lu AG06466

    Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12

    Vz/F is defined as CL/F * t1/2 / ln2.

  11. Apparent Elimination Half-life (t1/2) of Lu AG06466

    Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12

  12. t1/2 of Metabolite Lu AG06988

    Time frame: 0 (predose) up to 72 hours postdose on Day 1 to Day 12

  13. Metabolic Ratio (MR)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 31, 2021
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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