Safety and Tolerability Study of Lu AG06466 in Healthy Young Japanese and Caucasian Participants

Healthy Volunteers Clinical Trial

Official title:

Interventional, Randomized, Double-Blind, Sequential-Part, Placebo-Controlled, Single- and Multiple-Dose Study Investigating Safety, Tolerability, and Pharmacokinetic Properties of Lu AG06466 in Healthy Young Japanese and Caucasian Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05177029
• Other study ID #: 19891A
• Status: Terminated
• Phase: Phase 1
• Start date: November 26, 2021
• Est. completion date: December 29, 2021

Study information

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

Clinical Trial Summary

The main goal of this study is to evaluate the effect of Lu AG06466 on the body and what the body does to Lu AG06466 after single and multiple doses to healthy Japanese and Caucasian participants.

Description:

This sequential study will be divided in two parts, Part A and Part B. Part A will consist of 3 cohorts (Cohorts A1, A2, and A3) in which participants will be randomized to receive a single dose of Lu AG046466 or a matching placebo orally. After completing the safety review of data from Cohort A1, the study will proceed in Cohorts A2 and A3, with an increased dose of Lu AG046466 or matching placebo being administered to Japanese and Caucasian participants. Part B dosing will only be initiated after completion of Part A. Part B will consist of 1 cohort (Cohort B1), to which multiple dose of Lu AG046466 or matching placebo will be administered after dose titration.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: December 29, 2021
• Est. primary completion date: December 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• The participant has a BMI =18.5 and =25 kilograms (kg)/square meter (m^2) or =30 kg/m^2 for Japanese and Caucasian participants, respectively, and a body weight =50 kilograms (kg) 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, a neurological examination, vital signs, electrocardiograms (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

• The participant has taken disallowed medication <1 week prior to the first dose of study drug or <5 half-lives of the disallowed medication as concomitant use prior to the screening visit.
• 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.
• The participant has had a clinically significant illness <4 weeks prior to the first dose of study drug.
• The participant has received a SARS-CoV-2 (COVID-19) vaccination <30 days prior to the first dose of study drug. Note: Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Lu AG06466
Lu AG06466 will be administered per schedule specified in the arm.
• Placebo
Placebo matching to Lu AG06466 will be administered per schedule specified in the arm.

Locations

Country	Name	City	State
Japan	P-One Clinic, Keikokai Medical Corporation	Yokamachi Hachioji City	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Number of Participants With Adverse Events		Baseline up to Day 12
Primary	Part B: Number of Participants With Adverse Events		Baseline up to Day 26
Primary	Part A: Area Under the Plasma Concentration-Time Curve of Lu AG06466 and Metabolite Lu AG06988 From Zero to Infinity (AUC0-inf)		0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
Primary	Part B: Area Under the Plasma Concentration-Time Curve of Lu AG06466 and Metabolite Lu AG06988 in a Dosing Interval (AUC0-t)		0 (pre-dose) up to 24 hours post-dose on Day 15
Primary	Part A: Maximum Observed Plasma Concentration (Cmax) of Lu AG06466 and Metabolite Lu AG06988		0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
Primary	Part B: Cmax of Lu AG06466 and Metabolite Lu AG06988		0 (pre-dose) up to 24 hours post-dose on Day 1 and Day 15
Primary	Part A: Nominal Time Corresponding to the Occurrence of Cmax (Tmax) of Lu AG06466 and Metabolite Lu AG06988		0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
Primary	Part B: Tmax of Lu AG06466 and Metabolite Lu AG06988		0 (pre-dose) up to 24 hours post-dose on Day 1 and Day 15
Primary	Part A: Apparent Elimination Half-Life (t1/2) of Lu AG06466 and Metabolite Lu AG06988		0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3
Primary	Part B: t1/2 of Lu AG06466 and Metabolite Lu AG06988		0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 17
Primary	Part A: Metabolic Ratio of AUC0-inf (MRAUC0-inf): AUC0-inf, Lu AG06988/AUC0-inf, Lu AG06466		0 (pre-dose) up to 48 hours post-dose on Day 1 to Day 3