A Study Investigating Lu AG06474 in Healthy Young Participants

NCT05943327 | Terminated Phase 1 FDA Drug

• 1 other identifier: 20065A
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety of multiple oral doses of Lu AG06474, how well the doses are tolerated, and what the body does to the drug after administering it to healthy young participants. This study also aims to compare how the body absorbs and uses Lu AG06474 when it is given in capsule form versus when it is given as an oral solution.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (9)

• Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs)

  Up to Day 10

• Part A: Electrocardiogram (ECG) Parameter (delta QTcF) on Day 5

  Day 5

• Part A: AUC0-τ: Area Under the Lu AG06474 Plasma Concentration Curve During Dosing Interval

  Predose to Day 7

• Parts A and B: Cmax: Maximum Observed Plasma Concentration of Lu AG06474

  Predose to Day 6

• Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax

  Predose to Day 6

• Parts A and B: t½: Apparent Elimination Half-life of Lu AG06474

  Predose to Day 6

• Part B: AUC0-infinity: Area Under the Lu AG06474 Plasma Concentration Curve From Zero to Infinity

  Predose to Day 6

• Part A: Accumulation Index

  Predose to Day 7

• Part B: Frel: Relative Bioavailability

  Predose to Day 6

Study Arms (2)

Part A: Multiple Doses of Lu AG06474 or Placebo

EXPERIMENTAL

Participants will receive multiple oral doses of Lu AG06474 or placebo.

Drug: Lu AG06474; Drug: Placebo

Part B: Single Doses of Lu AG06474

EXPERIMENTAL

Participants will receive single oral doses of Lu AG06474.

Drug: Lu AG06474

Interventions

Lu AG06474 DRUG

Oral Solution

Part A: Multiple Doses of Lu AG06474 or Placebo; Part B: Single Doses of Lu AG06474

Placebo DRUG

Oral Solution

Part A: Multiple Doses of Lu AG06474 or Placebo

Eligibility Criteria

• Age: 18 Years - 45 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 kilograms per meter squared (kg/m\^2) at the Screening Visit and at the Baseline Visit.
• The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit. For physically/athletically well-trained participants, the lower limit is ≥45 bpm.
• The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the Screening Visit and at the Baseline Visit.

You may not qualify if:

• The participant has previously been dosed with Lu AG06474.
• The participant has participated in a clinical trial \<30 days prior to the Screening Visit.
• The participant has taken any investigational medicinal product ≥30 days or \<5 half-lives of that product, whichever is longer, prior to the first dose of IMP.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Quotient Sciences Miami

Miami, Florida, 33126, United States

Location

Study Design

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

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 13, 2023
• Study Start: June 28, 2023
• Primary Completion: July 19, 2024
• Study Completion: July 19, 2024
• Last Updated: November 18, 2024

Record last verified: 2024-11

Locations

US (1)