A Trial Investigating Lu AF28996 in Healthy Adult Participants

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it.

Key facts

Study ID

NCT06277609

Run by

H. Lundbeck A/S

People needed

22

Starts

2024-02-27

Expected to finish

2024-05-19

Last updated by the study team

2024-06-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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 Safety Baseline Visit.
• The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Safety Baseline Visit.
• The participant has a resting supine systolic blood pressure ≥90 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥50 and ≤90 mmHg at the Screening Visit and at the Safety Baseline Visit.
• The participant has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.

You may not qualify if…

• The participant is a member of the site staff or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the site staff.
• Part B only, the participant is a woman of childbearing potential AND is using oral hormonal contraceptives.
• The participant has previously been enrolled in this trial.
• The participant has previously been dosed with Lu AF28996.
• Note: Other inclusion and exclusion criteria may apply.

Where it is running

• Covance Dallas CRU — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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