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

NCT05028673 | Completed Phase 1

• 1 other identifier: 19270A
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (4)

Lu AG06466 Capsule, Fasted State

EXPERIMENTAL

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

Drug: Lu AG06466 Capsule

Lu AG06466 Tablet, Fasted State

EXPERIMENTAL

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

Drug: Lu AG06466 Tablet

Lu AG06466 Tablet, Fed State

EXPERIMENTAL

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

Drug: Lu AG06466 Tablet

Lu AG06466 Tablet + Antacid, Fasted State

EXPERIMENTAL

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

Drug: Lu AG06466 Tablet; Drug: Antacid

Interventions

Lu AG06466 Capsule DRUG

Hard capsule

Lu AG06466 Capsule, Fasted State

Lu AG06466 Tablet DRUG

Film-coated tablet

Lu AG06466 Tablet + Antacid, Fasted State; Lu AG06466 Tablet, Fasted State; Lu AG06466 Tablet, Fed State

Antacid DRUG

Oral suspension

Also known as: Maalox, Aluminum hydroxide and magnesium hydroxide

Lu AG06466 Tablet + Antacid, Fasted State

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

LabCorp Clinical Research Unit Ltd

Leeds, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

Antacids; aluminum hydroxide, magnesium hydroxide, drug combination

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Gastrointestinal Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The first 3 periods will be randomized.

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: August 23, 2021
• Primary Completion: December 29, 2021
• Study Completion: December 29, 2021
• Last Updated: January 21, 2022

Record last verified: 2022-01

Locations

GB (1)