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

NCT05177029 | Terminated Phase 1

• 1 other identifier: 19891A
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (11)

• Part A: Number of Participants With Adverse Events

  Baseline up to Day 12

• Part B: Number of Participants With Adverse Events

  Baseline up to Day 26

• 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

• Part B: Area Under the Plasma Concentration-Time Curve of Lu AG06466 and Metabolite Lu AG06988 in a Dosing Interval (AUC0-τ)

  0 (pre-dose) up to 24 hours post-dose on Day 15

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Part A: Lu AG06466 or Placebo

EXPERIMENTAL

Participants will receive single dose of Lu AG06466 capsule or matching placebo orally on Day 1.

Drug: Lu AG06466; Drug: Placebo

Part B: Lu AG06466 or Placebo

EXPERIMENTAL

Participants will receive starting dose of Lu AG06466 capsule or matching placebo orally once daily from Day 1 to Day 4 followed by Lu AG06466 capsule or matching placebo at a titrated treatment dose orally once daily from Day 5 until Day 8. Participants will then receive LuAG06466 capsule or matching placebo at a higher assigned dose orally once daily from Day 9 to Day 15.

Drug: Lu AG06466; Drug: Placebo

Interventions

Lu AG06466 DRUG

Lu AG06466 will be administered per schedule specified in the arm.

Part A: Lu AG06466 or Placebo; Part B: Lu AG06466 or Placebo

Placebo DRUG

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

Part A: Lu AG06466 or Placebo; Part B: Lu AG06466 or Placebo

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

P-One Clinic, Keikokai Medical Corporation

Yokamachi Hachioji City, Tokyo, 192-0071, Japan

Location

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: November 26, 2021
• Primary Completion: December 29, 2021
• Study Completion: December 29, 2021
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

JP (1)