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Lu AG06474 for Healthy Subjects

Phase 1
Waitlist Available
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 pre-dose baseline (day -1), day 4
Awards & highlights

Study Summary

This trial investigates the safety and how the body processes a single dose of Lu AG06474.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose baseline (day -1), day 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose baseline (day -1), day 4 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: Bond-Lader VAS Dimension Scores at Day 4
Part A: Change From Pre-Dose Baseline in ECG Parameter (Delta QTcF) at 24 Hours on Day 1
Part A: Change From Pre-Dose Baseline in the Bond-Lader VAS Dimension Scores at Day 4
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Repeated Dose of Lu AG06474 and Food InteractionExperimental Treatment1 Intervention
Participants will receive a single oral dose of Lu AG06474 in each dosing period (Period 1, 2, and 3) in the following sequence: Sequence B1: Fed - Fasting- Fasting Sequence B2: Fasting- Fed - Fasting Sequence B3: Fasting- Fasting - Fed
Group II: Part A: Single Dose of Lu AG06474 or PlaceboExperimental Treatment2 Interventions
Participants will receive single oral dose of Lu AG06474 or placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Lu AG06474
2021
Completed Phase 1
~80

Find a Location

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
77,504 Total Patients Enrolled
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
188 Previous Clinical Trials
58,261 Total Patients Enrolled

Frequently Asked Questions

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

Are those younger than 65 years of age admissible for this investigation?

"The age range requirement for this trial is 18 to 45 years old."

Answered by AI

Are any additional participants being accepted for this investigation?

"Confirmed, this clinical trial is actively searching for participants. It was published on August 4th 2021 and the last update was issued November 7th 2022."

Answered by AI

Who is an eligible candidate for participation in this trial?

"84 healthy subjects aged 18 to 45, with a body mass index (BMI) ranging from 18.5 and 30 kilograms/square meter is required for this clinical trial. These criteria must be present at both the screening visit and safety baseline/baseline visit."

Answered by AI

What is the cap on participation in this research endeavor?

"Affirmative. According to the official information on clinicaltrials.gov, this trial is presently recruiting participants and was initially posted back in August 4th 2021. The study requires 84 volunteers at a single site for completion."

Answered by AI

Has Lu AG06474 been approved by the Federal Drug Administration?

"Due to limited data available on Lu AG06474, Power's estimations of the substance's safety are ranked at 1 on a scale from 1-3. This is expected for Phase 1 trials as there has been minimal testing conducted concerning efficacy and protection."

Answered by AI

Who else is applying?

What state do they live in?
New Mexico
Illinois
Other
Florida
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Quotient Sciences Miami
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'd love to do a clinical trial in Miami.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Quotient Sciences Miami: < 48 hours
Recent research and studies
clinicaltrials.govStudy
Safety and Tolerability of Lu AG06474 in Healthy Young Men
2021. "Safety and Tolerability of Lu AG06474 in Healthy Young Men". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05003687.
~22 spots leftby Apr 2025
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