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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05028673
• Other study ID #: 19270A
• Status: Completed
• Phase: Phase 1
• Start date: August 23, 2021
• Est. completion date: December 29, 2021

Study information

• Verified date: January 2022
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 29, 2021
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lu AG06466 Capsule
Hard capsule
• Lu AG06466 Tablet
Film-coated tablet
• Antacid
Oral suspension

Locations

Country	Name	City	State
United Kingdom	LabCorp Clinical Research Unit Ltd	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	AUC0-tlast of Metabolite Lu AG06988		0 (predose) up to 72 hours postdose on Day 1 to Day 12
Primary	Maximum Observed Plasma Concentration (Cmax) of Lu AG06466		0 (predose) up to 72 hours postdose on Day 1 to Day 12
Primary	Cmax of Metabolite Lu AG06988		0 (predose) up to 72 hours postdose on Day 1 to Day 12
Primary	Time to Reach Cmax (Tmax) of Lu AG06466		0 (predose) up to 72 hours postdose on Day 1 to Day 12
Primary	Tmax of Metabolite Lu AG06988		0 (predose) up to 72 hours postdose on Day 1 to Day 12
Primary	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
Primary	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
Primary	Apparent Elimination Half-life (t1/2) of Lu AG06466		0 (predose) up to 72 hours postdose on Day 1 to Day 12
Primary	t1/2 of Metabolite Lu AG06988		0 (predose) up to 72 hours postdose on Day 1 to Day 12
Primary	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