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Lu AG06474 for Healthy Volunteers

Phase 1
Recruiting
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 10
Awards & highlights

Study Summary

This trial looks at the safety and absorption of a drug in healthy volunteers to see if it is effective in treating a condition.

Who is the study for?
This trial is for healthy young adults with a BMI between 18.5 and 30, normal blood pressure (91-140/51-85 mmHg), and pulse rate (50-100 bpm; ≥45 for athletes). Participants must not have taken any investigational drugs or participated in other clinical trials within the last 30 days.Check my eligibility
What is being tested?
The study tests multiple oral doses of Lu AG06474 to assess safety, tolerance, and how the body processes it. It also compares absorption when given as a capsule versus an oral solution. Some participants will receive a placebo instead of the active drug.See study design
What are the potential side effects?
Since this is an early-stage trial focusing on healthy individuals, specific side effects are not listed but generally could include reactions at varying degrees such as nausea, headache, dizziness or allergic responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: AUC0-τ: Area Under the Lu AG06474 Plasma Concentration Curve During Dosing Interval
Part A: Accumulation Index
Part A: Electrocardiogram (ECG) Parameter (delta QTcF) on Day 5
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Single Doses of Lu AG06474Experimental Treatment1 Intervention
Participants will receive single oral doses of Lu AG06474.
Group II: Part A: Multiple Doses of Lu AG06474 or PlaceboExperimental Treatment2 Interventions
Participants will receive multiple oral doses of Lu AG06474 or placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lu AG06474
2021
Completed Phase 1
~80
Placebo
1995
Completed Phase 3
~2670

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

H. Lundbeck A/SLead Sponsor
325 Previous Clinical Trials
77,515 Total Patients Enrolled

Media Library

Part B: Single Doses of Lu AG06474 Clinical Trial Eligibility Overview. Trial Name: NCT05943327 — Phase 1
Healthy Subjects Research Study Groups: Part B: Single Doses of Lu AG06474, Part A: Multiple Doses of Lu AG06474 or Placebo
Healthy Subjects Clinical Trial 2023: Part B: Single Doses of Lu AG06474 Highlights & Side Effects. Trial Name: NCT05943327 — Phase 1
Part B: Single Doses of Lu AG06474 2023 Treatment Timeline for Medical Study. Trial Name: NCT05943327 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is Lu AG06474 a safe treatment for patients when administered in one dose?

"There is limited data on the efficacy and safety of Part B: Single Doses of Lu AG06474, so its score was set at a 1."

Answered by AI

Are mature individuals being sought out for this clinical research?

"The upper and lower bounds for participants in this medical trial are 18-45 years old. Additionally, there exist 56 studies specifically for minors and 370 trials dedicated to seniors over 65."

Answered by AI

For whom would this clinical trial be most appropriate?

"To qualify for this medical trial, subjects must meet the criteria of healthy and aged between 18 to 45 years old. This research is taking 68 participants in total."

Answered by AI

How many participants have been accepted to partake in this experiment?

"Affirmative. Clinicaltrials.gov provides evidence that recruitment for this medical study is in progress, the trial having been initially published on June 28th 2023 and most recently updated July 10th 2023. 68 individuals are sought out at a single site."

Answered by AI

Are any fresh patients being sought for this investigation?

"As indicated on the clinicaltrials.gov website, this medical research is presently recruiting patients for participation. The study was initially posted upon 28th of June 2023 and had its last update on July 10th 2023."

Answered by AI

Who else is applying?

What site did they apply to?
Quotient Sciences Miami
Quotient
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

I am interested in volunteering for a good cause.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study Investigating Lu AG06474 in Healthy Young Participants
2023. "A Study Investigating Lu AG06474 in Healthy Young Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05943327.
~16 spots leftby Aug 2024
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