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Part A: Lu AF28996 with Enzyme Inhibitors for Healthy Subjects

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 predose to day 13
Awards & highlights

Study Summary

This trial will look at how healthy participants tolerate repeated doses of Lu AF28996 when taken alone and when taken with two other compounds. They will also study how the body processes the drug when taken with

Who is the study for?
This trial is for healthy adults with normal blood pressure and heart rate, a regular sleep-wake cycle (waking up between 6-9 AM and sleeping between 9 PM-midnight), and a BMI between 18.5 to 30. Participants must maintain these criteria from screening through the start of the study.Check my eligibility
What is being tested?
The study tests repeated doses of Lu AF28996 on its own, alongside two other compounds, and after taking antibiotics in different groups to understand how well participants tolerate it and how their bodies process the drug.See study design
What are the potential side effects?
Potential side effects are not specified but may include reactions typical to medication trials such as nausea, headache, allergic reactions or changes in blood pressure or heart rate due to the nature of pharmaceutical studies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose to day 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose to day 13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AF28996
Maximum Observed Concentration (Cmax) of Lu AF28996
Secondary outcome measures
Nominal Time Corresponding to the Occurrence of Cmax

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Lu AF28996 with AntibioticsExperimental Treatment2 Interventions
Participants will receive single doses of Lu AF28996 and amoxicillin/clavulanic acid.
Group II: Part A: Lu AF28996 with Enzyme InhibitorsExperimental Treatment3 Interventions
Participants will receive repeated single doses of Lu AF28996 and enzyme inhibitors.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lu AF28996
2023
Completed Phase 1
~10
Acetylsalicylic Acid
2013
Completed Phase 3
~16190
Amoxicillin/clavulanic acid
2019
Completed Phase 4
~540

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
77,559 Total Patients Enrolled

Frequently Asked Questions

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

Is this clinical trial currently open to new participants?

"Yes, the information available on clinicaltrials.gov indicates that this particular trial is actively seeking individuals to participate. The trial was first made public on February 27th, 2024 and underwent its last revision on March 6th, 2024. Recruitment aims to enroll a total of 24 participants from one designated location."

Answered by AI

Has the combination of Lu AF28996 with antibiotics been granted approval by the FDA in Part B?

"The safety assessment for Part B: Lu AF28996 with Antibiotics has been rated as 1 by our team at Power. This rating is due to the trial being in its initial Phase 1 stage, where there exists minimal evidence supporting both safety and effectiveness."

Answered by AI

Is there a possibility for me to partake in this clinical trial?

"The trial is seeking 24 participants aged between 18 and 55 who are in good health. Eligible individuals must have a resting supine systolic blood pressure ranging from ≥90 to ≤140 mmHg, and a diastolic blood pressure of ≥50 to ≤90 mmHg during both the Screening Visit and Safety Baseline Visit. They should exhibit a regular circadian rhythm, typically awakening between 6:00 to 9:00 a.m. and retiring for sleep between 9:00 p.m. to midnight. Additionally, their resting supine pulse rate should be within the range of ≥50 to ≤"

Answered by AI

How many individuals are partaking in this clinical trial as participants overall?

"Yes, the details available on clinicaltrials.gov suggest that this medical investigation is presently seeking participants. This trial was initially listed on February 27th, 2024, and its most recent update was recorded on March 6th, 2024. The aim is to enroll a total of 24 individuals from one designated site."

Answered by AI

Is the trial open to participants who have not yet reached their 80th birthday?

"Recruitment for this trial is limited to individuals over 18 years of age but under the age of 55."

Answered by AI

Who else is applying?

What site did they apply to?
Covance Dallas CRU
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Trial Investigating Lu AF28996 in Healthy Adult Participants
2024. "A Trial Investigating Lu AF28996 in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06277609.
All > Dallas > Durlaza
~0 spots leftby May 2024
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