Clincosm LogoSign in Get a demo

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

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT05028673
Collaborator
(none)
16
Enrollment
1
Location
4
Arms
4.2
Actual Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
The first 3 periods will be randomized.The first 3 periods will be randomized.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 23, 2021
Actual Primary Completion Date :
Dec 29, 2021
Actual Study Completion Date :
Dec 29, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466 [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 [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 [0 (predose) up to 72 hours postdose on Day 1 to Day 12]

    4. AUC0-tlast of Metabolite Lu AG06988 [0 (predose) up to 72 hours postdose on Day 1 to Day 12]

    5. Maximum Observed Plasma Concentration (Cmax) of Lu AG06466 [0 (predose) up to 72 hours postdose on Day 1 to Day 12]

    6. Cmax of Metabolite Lu AG06988 [0 (predose) up to 72 hours postdose on Day 1 to Day 12]

    7. Time to Reach Cmax (Tmax) of Lu AG06466 [0 (predose) up to 72 hours postdose on Day 1 to Day 12]

    8. Tmax of Metabolite Lu AG06988 [0 (predose) up to 72 hours postdose on Day 1 to Day 12]

    9. Apparent Oral Clearance (CL/F) of Lu AG06466 [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 [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 [0 (predose) up to 72 hours postdose on Day 1 to Day 12]

    12. t1/2 of Metabolite Lu AG06988 [0 (predose) up to 72 hours postdose on Day 1 to Day 12]

    13. Metabolic Ratio (MR) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 LabCorp Clinical Research Unit Ltd Leeds United Kingdom LS2 9LH

    Sponsors and Collaborators

    • H. Lundbeck A/S

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    H. Lundbeck A/S
    ClinicalTrials.gov Identifier:
    NCT05028673
    Other Study ID Numbers:
    • 19270A
    First Posted:
    Aug 31, 2021
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Aluminum Hydroxide
    Antacids
    Magnesium Hydroxide

    Study Results

    No Results Posted as of Jan 21, 2022